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Starting with our Chief Executive Officer, our commitment to quality is ingrained in our company culture and in every employee and we have harmonized our quality management system across all sites around the world for the production of biologics or vaccines drug substance and drug product. We start with our quality manual and our quality system encompasses documentation management and control, personnel training, supplier management, change management, OOS and deviation management, data integrity, CAPA, audits and inspections, risk management, compliance management, IP protection and regulatory intelligence."> <meta name="google-site-verification" content="qFjg-uvUf2PUE8xqLVrfs5ode6wqXy3BSQtjZkle-Gc" />     <meta property="og:description" content="We have established a global quality system, quality control and operational systems that meet or exceed worldwide regulatory standards from the U.S. FDA, EMA, NMPA and other major regulatory agencies. Starting with our Chief Executive Officer, our commitment to quality is ingrained in our company culture and in every employee and we have harmonized our quality management system across all sites around the world for the production of biologics or vaccines drug substance and drug product. We start with our quality manual and our quality system encompasses documentation management and control, personnel training, supplier management, change management, OOS and deviation management, data integrity, CAPA, audits and inspections, risk management, compliance management, IP protection and regulatory intelligence."> <meta property="og:image" content="https://www.wuxibiologics.com/wp-content/uploads/webCover.jpg" /> <meta property="og:image:secure_url" content="https://www.wuxibiologics.com/wp-content/uploads/webCover.jpg" /> <meta property="og:image:type" content="image/jpeg" /> <meta property="og:image:width" content="512" /> <meta property="og:image:height" content="512" /> <script type="text/javascript" src="https://www.wuxibiologics.com/wp-content/themes/Divi-child/ens/js/jquery.min.js"></script> <meta name='robots' content='index, follow, max-image-preview:large, max-snippet:-1, max-video-preview:-1' /> <script type="text/javascript"> let 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hover"> <div class="container d-flex align-items-center justify-content-between"> <div class="logo"><a href="https://www.wuxibiologics.com"><img src="https://www.wuxibiologics.com/wp-content/themes/Divi-child/ens/images/logo.svg" alt=""></a></div> <div class="header-menu-pc header-menu d-flex align-items-center justify-content-between"> <div class="header-nav is_active"> <div class="menu-main-container"><ul id="menu-main" class="menu"><li id="menu-item-19909" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19909"><a>About Us</a><div class="second-level"><div class="container d-flex"><div class="second-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title">About Us</div></div><ul class="sub-menu second-level-nav d-flex justify-content-start"> <li id="menu-item-19910" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-19910"><a href="https://www.wuxibiologics.com/company/">Company</a><ul class="sub-menu"> <li id="menu-item-19911" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19911"><a href="https://www.wuxibiologics.com/company/#Vision_Mission">Vision & Mission</a></li> <li id="menu-item-19912" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19912"><a href="https://www.wuxibiologics.com/company/#Culture">Culture</a></li> <li id="menu-item-19917" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19917"><a href="https://www.wuxibiologics.com/company/#History_Awards">History & Awards</a></li> <li id="menu-item-19918" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19918"><a href="https://www.wuxibiologics.com/company/#Business_Ethics">Business Ethics</a></li> </ul></li> <li id="menu-item-19908" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-19908"><a href="https://www.wuxibiologics.com/leadership/">Leadership</a></li> <li id="menu-item-19920" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-19920"><a href="https://www.wuxibiologics.com/scientific-advisory-board/">Scientific Advisory Board</a></li> <li id="menu-item-19922" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-19922"><a href="https://www.wuxibiologics.com/locations-facilities/">Locations & Facilities</a></li> </ul></div></div></li> <li id="menu-item-19921" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-ancestor menu-item-has-children menu-item-19921"><a>Services & Capabilities</a><div class="second-level"><div class="container d-flex"><div class="second-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title">About Us</div></div><ul class="sub-menu second-level-nav d-flex justify-content-start"> <li id="menu-item-19923" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19923"><a>Production Systems</a><ul class="sub-menu"> <li id="menu-item-19924" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19924"><a>Mammalian<p class="img-description">$Our expertise spans discovery, development, and cGMP manufacture of biologics from mammalian cell culture. Leveraging 6 discovery platforms, a top-tier CMC development team, and an extensive supply chain, we deliver seamless programs for all your biologics drug development needs.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex align-items-center"><svg height="12" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 18 11" style="transform:rotate(-180deg)"><defs><style>.line{fill:#555555;fill-rule:evenodd;}</style></defs><path class="line" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg> Back</a></li> <li id="menu-item-19925" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19925"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/">Mammalian-Derived Product Services<p class="img-description">$A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.</p></a><div class="menu-item-description"><p class="img-title">Mammalian-Derived Product Services</p><p class="img-description">A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19926" class="link-intro menu-item menu-item-type-custom menu-item-object-custom menu-item-19926"><a>Product types we support:</a></li> <li id="menu-item-19927" class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19927"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/monoclonal-antibodies/">Monoclonal Antibodies<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Monoclonal Antibodies</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/monoclonal-antibodies/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19928" class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19928"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/bispecific-multispecific-antibodies/">Bispecific & Multispecific Antibodies<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Bispecific & Multispecific Antibodies</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/bispecific-multispecific-antibodies/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19929" class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19929"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/fc-fusion-proteins/">Fc-Fusion Proteins<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Fc-Fusion Proteins</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/fc-fusion-proteins/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19930" class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19930"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/antibody-fragments/">Antibody Fragments<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Antibody Fragments</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/antibody-fragments/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" 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E. coli and yeast-based expression systems for the production of plasmid DNA and recombinant proteins.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex align-items-center"><svg height="12" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 18 11" style="transform:rotate(-180deg)"><defs><style>.line{fill:#555555;fill-rule:evenodd;}</style></defs><path class="line" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg> Back</a></li> <li id="menu-item-19936" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19936"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/">Microbial-Derived Product Services<p class="img-description">$High quality, expert services for biologics produced from microbial fermentation.</p></a><div class="menu-item-description"><p class="img-title">Microbial-Derived Product Services</p><p class="img-description">High quality, expert services for biologics produced from microbial fermentation.</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" 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class="menu-item-description"><p class="img-title">Enzymes / Cytokines</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/enzyme_cytokine/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19940" class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19940"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/plasmid-dna/">Plasmid DNA (pDNA)<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Plasmid DNA (pDNA)</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/plasmid-dna/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19941" class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19941"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/virus-like-particles/">Virus-Like Particles (VLPs)<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Virus-Like Particles (VLPs)</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/virus-like-particles/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" 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class="menu-item-description"><p class="img-title">Cell Line Engineering</p><p class="img-description">Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.</p><p><a href="https://www.wuxibiologics.com/capabilities/cell-line-engineering/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19951" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19951"><a href="https://www.wuxibiologics.com/capabilities/analytical-development/">Analytical Sciences<p class="img-description">$Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.</p></a><div class="menu-item-description"><p class="img-title">Analytical Sciences</p><p class="img-description">Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.</p><p><a href="https://www.wuxibiologics.com/capabilities/analytical-development/" 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class="menu-item-description"><p class="img-title">Process Development & Scale Up</p><p class="img-description">Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.</p><p><a href="https://www.wuxibiologics.com/capabilities/process-development-scale-up/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19953" class="menu-item menu-item-type-custom 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capacity availability and timely execution of this critical CMC development activity.</p></a><div class="menu-item-description"><p class="img-title">Cell Banking & Characterization</p><p class="img-description">Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.</p><p><a href="https://www.wuxibiologics.com/capabilities/cell-banking/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" 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program.</p><p><a href="https://www.wuxibiologics.com/capabilities/biosafety-testing/#ViralClearanceStudies" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19956" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19956"><a href="https://www.wuxibiologics.com/capabilities/regulatory-support/">Regulatory Support<p class="img-description">$Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.</p></a><div class="menu-item-description"><p class="img-title">Regulatory Support</p><p class="img-description">Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.</p><p><a href="https://www.wuxibiologics.com/capabilities/regulatory-support/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul></div> <div class="lower-menu"> <div class="container"> <ul class="d-flex align-items-center justify-content-end"> 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menu-item-object-custom menu-item-has-children menu-item-19957"><a>Manufacturing<p class="img-description">$Multiple state-of-the-art, premier quality cGMP clinical- and commercial-scale drug substance (DS) and drug product (DP) facilities across four countries for the production of a wide array of biologics from both mammalian and microbial expression systems.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex align-items-center"><svg height="12" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 18 11" style="transform:rotate(-180deg)"><defs><style>.line{fill:#555555;fill-rule:evenodd;}</style></defs><path class="line" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg> Back</a></li> <li id="menu-item-22252" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-22252"><a href="https://www.wuxibiologics.com/capabilities/clinical-ds-manufacturing/">Clinical DS GMP Manufacturing<p class="img-description">$Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.</p></a><div class="menu-item-description"><p class="img-title">Clinical DS GMP Manufacturing</p><p class="img-description">Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.</p><p><a href="https://www.wuxibiologics.com/capabilities/clinical-ds-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-22253" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-22253"><a href="https://www.wuxibiologics.com/capabilities/clinical-dp-manufacturing/">Clinical DP GMP Manufacturing<p class="img-description">$Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.</p></a><div class="menu-item-description"><p class="img-title">Clinical DP GMP Manufacturing</p><p class="img-description">Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.</p><p><a href="https://www.wuxibiologics.com/capabilities/clinical-dp-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19958" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19958"><a href="https://www.wuxibiologics.com/capabilities/commercial-ds-manufacturing/">Commercial DS GMP Manufacturing<p class="img-description">$We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.</p></a><div class="menu-item-description"><p class="img-title">Commercial DS GMP Manufacturing</p><p class="img-description">We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.</p><p><a href="https://www.wuxibiologics.com/capabilities/commercial-ds-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19959" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19959"><a href="https://www.wuxibiologics.com/capabilities/commercial-dp-manufacturing/">Commercial DP GMP Manufacturing<p class="img-description">$Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.</p></a><div class="menu-item-description"><p class="img-title">Commercial DP GMP Manufacturing</p><p class="img-description">Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.</p><p><a href="https://www.wuxibiologics.com/capabilities/commercial-dp-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 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d="M177.1,125.6c-0.5,1.8-1,3.4-1.6,5c-2.5,8.2-5.1,16.3-7.6,24.5c-0.3,0.9-0.6,1.2-1.5,1.1c-1.1-0.1-2.3,0.3-3.1-0.2c-0.8-0.5-0.8-1.9-1.1-2.9c-2.7-8.8-5.4-17.6-8.1-26.3c-0.1-0.3-0.3-0.7-0.2-1.2c1.1,0,2.2,0,3.2,0c0.8,0,0.7,0.7,0.9,1.1c1.5,5.2,3,10.4,4.5,15.6c0.8,2.8,1.6,5.6,2.5,8.5c0.1,0.4,0.3,0.8,0.4,1.2c0.5-0.4,0.5-0.8,0.6-1.2c2.3-8,4.6-15.9,6.9-23.9c0.3-1,0.7-1.4,1.8-1.3C175.4,125.7,176.2,125.6,177.1,125.6L177.1,125.6z"/><path class="st0" d="M192.2,153.2c-1,0.6-1.8,1.2-2.6,1.7c-2,1.2-4.1,1.7-6.5,1.2c-2.4-0.5-4.1-2-4.6-4.4c-0.6-2.5-0.1-4.8,2.1-6.5c2.2-1.7,4.8-2.4,7.5-2.9c1-0.2,2.1-0.4,3.2-0.5c0.6-0.1,0.8-0.3,0.7-0.9c-0.2-3.5-2.3-5.2-5.8-4.7c-1.9,0.3-3.6,1.2-5.3,2.1c-0.1-0.1-0.2-0.1-0.2-0.2c-1.6-2.7-1.9-2.1,0.9-3.5c2.4-1.2,5-1.9,7.8-1.6c3,0.4,4.9,2.1,5.8,4.9c0.3,1.1,0.5,2.2,0.5,3.4c0,4.6,0,9.2,0,13.7c0,0.7-0.1,1.1-1,1.1c-2,0-2,0-2.3-2C192.4,154,192.3,153.6,192.2,153.2L192.2,153.2zM192,147.4v-1.1c0-2.2,0-2.2-2.1-1.8c-2.2,0.4-4.4,0.8-6.3,2.2c-1.4,1-1.8,2.5-1.4,4.1c0.4,1.6,1.6,2.2,3,2.5c0.8,0.1,1.6,0,2.3-0.2c1.7-0.4,3.1-1.3,4.2-2.6c0.7-0.8,0.2-2,0.3-3C192,147.5,192,147.4,192,147.4L192,147.4z"/><path class="st0" 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d="M257.5,137.3c1.1-0.8,1.9-1.5,2.8-2.2c1.8-1.4,4-1.8,6.2-1.4c2.4,0.4,3.9,1.9,4.7,4.2c0.5,1.5,0.6,3,0.6,4.5c0,4.3,0,8.5,0,12.8c0,0.9-0.2,1.2-1.2,1.2c-2.6-0.1-2.6,0-2.6-2.6c0-3.9,0-7.9,0-11.8c0-0.4-0.1-0.9-0.1-1.3c-0.5-3.7-3.7-4.2-6-3.2c-1.4,0.6-2.5,1.6-3.7,2.6c-0.4,0.4-0.3,0.9-0.3,1.4c0,4.6,0,9.2,0,13.7c0,0.9-0.2,1.3-1.2,1.2c-2.6-0.1-2.6,0-2.6-2.6c0-6.1,0-12.2,0-18.3c0-1,0.2-1.4,1.2-1.2c0.3,0.1,0.7,0,1,0c0.7-0.1,0.9,0.2,1,0.9C257.3,135.8,257.4,136.4,257.5,137.3L257.5,137.3z"/><path class="st0" d="M216.9,150.9c0.2,0.4,0.4,0.7,0.6,1c0.7,1.1,0.5,2-0.6,2.7c-6.5,4.1-14.5,0.4-15.7-7.1c-0.5-3.1-0.2-6.1,1.3-8.9c3.1-5.9,11-7.3,15.6-2.8c0,0.1-0.1,0.2-0.2,0.3c-0.5,0.7-0.9,1.6-1.5,1.9c-0.7,0.3-1.2-0.7-1.9-1c-2.8-1.4-6.2-0.5-8,2.2c-2.1,3.1-2,8.4,0.2,11.4c1.9,2.7,5.6,3.4,8.7,1.6C215.8,151.8,216.2,151.4,216.9,150.9L216.9,150.9z"/><path class="st0" d="M237.7,135.7c-0.6,0.8-1.2,1.6-1.8,2.3c-0.4,0-0.6-0.3-0.8-0.4c-3-2.5-7.3-1.5-9.2,1.8c-2,3.4-2,7.1-0.1,10.5c1.9,3.3,6,4.2,9.3,2.1c0.4-0.3,0.9-0.6,1.3-1c0.4,0.2,0.5,0.6,0.7,0.9c0.7,1.1,0.6,2-0.5,2.6c-6.6,4.2-14.8,0.3-15.8-7.5c-0.4-3.6,0-6.9,2.1-9.9C226.5,132.4,233.2,131.7,237.7,135.7L237.7,135.7z"/><path class="st0" d="M243,145.1c0-3.3,0-6.5,0-9.8c0-0.8,0.1-1.1,1.1-1.1c2.7,0,2.7,0,2.7,2.7c0,6,0,12,0,18c0,1-0.1,1.4-1.3,1.4c-2.5-0.1-2.5,0-2.5-2.5L243,145.1L243,145.1z"/><path class="st0" d="M136.2,122.3c-1.3,0-2.6,0-3.9,0c-0.6,0-0.8-0.2-0.8-0.8c0-2.5,0-5.1,0-7.6c0-0.6,0.2-0.8,0.8-0.8c2.6,0,5.2,0,7.7,0c0.6,0,0.8,0.2,0.8,0.8c0,2.5,0,5,0,7.5c0,0.6-0.2,0.9-0.8,0.8C138.7,122.3,137.5,122.3,136.2,122.3L136.2,122.3z"/><path class="st0" d="M247.3,128c0,1.3-1.1,2.4-2.4,2.4c-1.3,0-2.4-1.1-2.4-2.4c0-1.3,1.1-2.4,2.4-2.4C246.2,125.6,247.3,126.7,247.3,128L247.3,128z"/></g></g></svg> </a></li> </ul> </div> </div> </div></li> <li id="menu-item-19960" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19960"><a>Testing<p class="img-description">$We provide extensive expertise for in-process, characterization, release and stability method development and testing either in support of our integrated biologics development platforms or as standalone projects. Our wide-range of analytical and biosafety testing Centers of Excellence and regulatory agency-approved quality control (QC) laboratories are the backbone of every service we provide our clients.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex align-items-center"><svg height="12" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 18 11" style="transform:rotate(-180deg)"><defs><style>.line{fill:#555555;fill-rule:evenodd;}</style></defs><path class="line" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg> Back</a></li> <li id="menu-item-19961" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19961"><a href="https://www.wuxibiologics.com/capabilities/biosafety-testing/">Biosafety Testing<p class="img-description">$High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.</p></a><div class="menu-item-description"><p class="img-title">Biosafety Testing</p><p class="img-description">High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.</p><p><a href="https://www.wuxibiologics.com/capabilities/biosafety-testing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19962" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19962"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/">Analytical Testing<p class="img-description">$We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.</p></a><div class="menu-item-description"><p class="img-title">Analytical Testing</p><p class="img-description">We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.</p><p><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p><ul class="fourth-level"> <li id="menu-item-23361" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23361"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/bioassay-method-development-services/">Bioassay Method Development Services</a></li> <li id="menu-item-23362" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23362"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/product-characterization-services/">Product Characterization Services</a></li> <li id="menu-item-23363" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23363"><a 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d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19964" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19964"><a href="https://www.wuxibiologics.com/capabilities/global-quality-control/">Global Quality Control (QC)<p class="img-description">$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p></a><div class="menu-item-description"><p class="img-title">Global Quality Control (QC)</p><p class="img-description">Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p><p><a href="https://www.wuxibiologics.com/capabilities/global-quality-control/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul></div> <div class="lower-menu"> <div class="container"> <ul class="d-flex align-items-center justify-content-end"> <li>Subsidiaries</li> <li><a href="https://wuxixdc.com/" target="_blank" class="d-flex"> <svg 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menu-item-object-custom current-menu-ancestor menu-item-has-children menu-item-19965"><a>Quality</a><ul class="sub-menu"> <li id="menu-item-19966" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-ancestor current-menu-parent menu-item-has-children menu-item-19966"><a>Quality & Regulatory<p class="img-description">$We provide world-class quality systems, harmonized across our global manufacturing sites and approved by multiple global regulatory agencies, including the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANVISA and Health Canada for the production and testing of a wide array of biologics.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex 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This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.</p></a><div class="menu-item-description"><p class="img-title">Global Compliance</p><p class="img-description">Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.</p><p><a href="https://www.wuxibiologics.com/quality/quality-compliance/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19968" class="menu-item menu-item-type-custom menu-item-object-custom current-menu-item menu-item-19968"><a href="https://www.wuxibiologics.com/quality/quality-assurance/" aria-current="page">Quality Assurance<p class="img-description">$Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.</p></a><div class="menu-item-description"><p class="img-title">Quality Assurance</p><p class="img-description">Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.</p><p><a href="https://www.wuxibiologics.com/quality/quality-assurance/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19969" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19969"><a href="https://www.wuxibiologics.com/quality/quality-control/">Quality Control<p class="img-description">$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p></a><div class="menu-item-description"><p class="img-title">Quality Control</p><p class="img-description">Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p><p><a href="https://www.wuxibiologics.com/quality/quality-control/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19970" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19970"><a href="https://www.wuxibiologics.com/quality/regulatory-affair/">Regulatory Affairs<p class="img-description">$Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.</p></a><div class="menu-item-description"><p class="img-title">Regulatory Affairs</p><p class="img-description">Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. 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d="M257.5,137.3c1.1-0.8,1.9-1.5,2.8-2.2c1.8-1.4,4-1.8,6.2-1.4c2.4,0.4,3.9,1.9,4.7,4.2c0.5,1.5,0.6,3,0.6,4.5c0,4.3,0,8.5,0,12.8c0,0.9-0.2,1.2-1.2,1.2c-2.6-0.1-2.6,0-2.6-2.6c0-3.9,0-7.9,0-11.8c0-0.4-0.1-0.9-0.1-1.3c-0.5-3.7-3.7-4.2-6-3.2c-1.4,0.6-2.5,1.6-3.7,2.6c-0.4,0.4-0.3,0.9-0.3,1.4c0,4.6,0,9.2,0,13.7c0,0.9-0.2,1.3-1.2,1.2c-2.6-0.1-2.6,0-2.6-2.6c0-6.1,0-12.2,0-18.3c0-1,0.2-1.4,1.2-1.2c0.3,0.1,0.7,0,1,0c0.7-0.1,0.9,0.2,1,0.9C257.3,135.8,257.4,136.4,257.5,137.3L257.5,137.3z"/><path class="st0" d="M216.9,150.9c0.2,0.4,0.4,0.7,0.6,1c0.7,1.1,0.5,2-0.6,2.7c-6.5,4.1-14.5,0.4-15.7-7.1c-0.5-3.1-0.2-6.1,1.3-8.9c3.1-5.9,11-7.3,15.6-2.8c0,0.1-0.1,0.2-0.2,0.3c-0.5,0.7-0.9,1.6-1.5,1.9c-0.7,0.3-1.2-0.7-1.9-1c-2.8-1.4-6.2-0.5-8,2.2c-2.1,3.1-2,8.4,0.2,11.4c1.9,2.7,5.6,3.4,8.7,1.6C215.8,151.8,216.2,151.4,216.9,150.9L216.9,150.9z"/><path class="st0" d="M237.7,135.7c-0.6,0.8-1.2,1.6-1.8,2.3c-0.4,0-0.6-0.3-0.8-0.4c-3-2.5-7.3-1.5-9.2,1.8c-2,3.4-2,7.1-0.1,10.5c1.9,3.3,6,4.2,9.3,2.1c0.4-0.3,0.9-0.6,1.3-1c0.4,0.2,0.5,0.6,0.7,0.9c0.7,1.1,0.6,2-0.5,2.6c-6.6,4.2-14.8,0.3-15.8-7.5c-0.4-3.6,0-6.9,2.1-9.9C226.5,132.4,233.2,131.7,237.7,135.7L237.7,135.7z"/><path class="st0" d="M243,145.1c0-3.3,0-6.5,0-9.8c0-0.8,0.1-1.1,1.1-1.1c2.7,0,2.7,0,2.7,2.7c0,6,0,12,0,18c0,1-0.1,1.4-1.3,1.4c-2.5-0.1-2.5,0-2.5-2.5L243,145.1L243,145.1z"/><path class="st0" d="M136.2,122.3c-1.3,0-2.6,0-3.9,0c-0.6,0-0.8-0.2-0.8-0.8c0-2.5,0-5.1,0-7.6c0-0.6,0.2-0.8,0.8-0.8c2.6,0,5.2,0,7.7,0c0.6,0,0.8,0.2,0.8,0.8c0,2.5,0,5,0,7.5c0,0.6-0.2,0.9-0.8,0.8C138.7,122.3,137.5,122.3,136.2,122.3L136.2,122.3z"/><path class="st0" d="M247.3,128c0,1.3-1.1,2.4-2.4,2.4c-1.3,0-2.4-1.1-2.4-2.4c0-1.3,1.1-2.4,2.4-2.4C246.2,125.6,247.3,126.7,247.3,128L247.3,128z"/></g></g></svg> </a></li> </ul> </div> </div> </div></li> <li id="menu-item-19976" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19976"><a>Discovery Technologies<p class="img-description">$A full spectrum of discovery services and technologies for the engineering, generation, characterization, optimization and selection of high-potency novel antibody therapeutics.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex align-items-center"><svg height="12" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 18 11" style="transform:rotate(-180deg)"><defs><style>.line{fill:#555555;fill-rule:evenodd;}</style></defs><path class="line" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="line" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg> Back</a></li> <li id="menu-item-19977" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19977"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#wuxibody">Bispecific & Multispecific Antibodies – WuXiBody™<p class="img-description">$The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.</p></a><div class="menu-item-description"><p class="img-title">Bispecific & Multispecific Antibodies - WuXiBody™</p><p class="img-description">The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#wuxibody" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19978" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19978"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#hybridoma">Advanced Hybridoma Platform – WuXiHybrid™<p class="img-description">$Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.</p></a><div class="menu-item-description"><p class="img-title">Advanced Hybridoma Platform - WuXiHybrid™</p><p class="img-description">Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#hybridoma" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19979" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19979"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#phage">Naive Phage Display Library – WuXiLiAb™<p class="img-description">$Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.</p></a><div class="menu-item-description"><p class="img-title">Naive Phage Display Library - WuXiLiAb™</p><p class="img-description">Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#phage" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19980" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19980"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#sdarbody">VHH-based Multispecific Antibody Platform – SDARBody™<p class="img-description">$Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.</p></a><div class="menu-item-description"><p class="img-title">VHH-based Multispecific Antibody Platform - SDARBody™</p><p class="img-description">Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#sdarbody" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19981" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19981"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#skybody">ScFv-based BsAb & MsAb Antibody Platform – SKYBody™<p class="img-description">$An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.</p></a><div class="menu-item-description"><p class="img-title">ScFv-based BsAb & MsAb Antibody Platform - SKYBody™</p><p class="img-description">An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#skybody" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-19982" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19982"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#single-b-cell-screening">VAST-B Single B-Cell Antibody Discovery Platform<p class="img-description">$An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.</p></a><div class="menu-item-description"><p class="img-title">VAST-B Single B-Cell Antibody Discovery Platform</p><p class="img-description">An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#single-b-cell-screening" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul></div> <div class="lower-menu"> <div class="container"> <ul class="d-flex align-items-center justify-content-end"> <li>Subsidiaries</li> <li><a href="https://wuxixdc.com/" target="_blank" class="d-flex"> <svg viewBox="0 0 459.75104 146.50754"><path 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menu-item-object-custom menu-item-has-children menu-item-19998"><a href="#">Development Technologies<p class="img-description">$Cutting-edge bioprocessing platforms and technologies designed to enable high-quality biologics to enter clinical trials faster, more efficiently and more cost-effectively.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex align-items-center"><svg height="12" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 18 11" style="transform:rotate(-180deg)"><defs><style>.line{fill:#555555;fill-rule:evenodd;}</style></defs><path class="line" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="line" 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manufacturing cost of goods compared to traditional fed-batch processes.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxiui/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-20000" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20000"><a href="https://www.wuxibiologics.com/featured-platforms/wuxian/">Rapid Research Material Generation – WuXian™<p class="img-description">$Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.</p></a><div class="menu-item-description"><p class="img-title">Rapid Research Material Generation - WuXian™</p><p class="img-description">Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxian/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-20001" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20001"><a href="https://www.wuxibiologics.com/featured-platforms/wuxia/">Cell Line Development – WuXia™<p class="img-description">$Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.</p></a><div class="menu-item-description"><p class="img-title">Cell Line Development - WuXia™</p><p class="img-description">Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxia/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-20002" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20002"><a href="https://www.wuxibiologics.com/featured-platforms/wuxiup/">Continuous Bioprocessing – WuXiUP™<p class="img-description">$This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.</p></a><div class="menu-item-description"><p class="img-title">Continuous Bioprocessing - WuXiUP™</p><p class="img-description">This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxiup/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-20003" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20003"><a href="https://wuxixdc.com/technologies-wuxidar4-adcs/">ADC Development Platform – WuXiDAR4™<p class="img-description">$Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.</p></a><div class="menu-item-description"><p class="img-title">ADC Development Platform - WuXiDAR4™</p><p class="img-description">Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.</p><p><a href="https://wuxixdc.com/technologies-wuxidar4-adcs/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-20004" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20004"><a href="https://www.wuxibiologics.com/featured-platforms/wuxihigh/#wuxi-high-concentration">High Concentration & HTP DP Platform – WuXiHigh™<p class="img-description">$Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.</p></a><div class="menu-item-description"><p class="img-title">High Concentration & HTP DP Platform - WuXiHigh™</p><p class="img-description">Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxihigh/#wuxi-high-concentration" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul></div> <div class="lower-menu"> <div class="container"> <ul class="d-flex align-items-center justify-content-end"> <li>Subsidiaries</li> <li><a href="https://wuxixdc.com/" target="_blank" class="d-flex"> <svg viewBox="0 0 459.75104 146.50754"><path 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menu-item-object-custom menu-item-has-children menu-item-20005"><a>Manufacturing Technologies<p class="img-description">$Advanced biomanufacturing platforms empower our global healthcare partners to deliver biologics to the clinic and on to the market for the benefit of patients worldwide.</p></a><div class="third-level"><div class="container d-flex justify-content-start"><div class="third-level-img"><div class="img_box img_icon"><img src="/wp-content/themes/Divi-child/ens/images/muen_icon01.png" alt=""></div> <div class="img_title"></div><div class="img_description"></div></div><ul class="sub-menu third-level-nav"><li class="back"><a class="d-flex align-items-center"><svg height="12" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 18 11" style="transform:rotate(-180deg)"><defs><style>.line{fill:#555555;fill-rule:evenodd;}</style></defs><path class="line" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="line" 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lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.</p></a><div class="menu-item-description"><p class="img-title">Scale-Out Biomanufacturing</p><p class="img-description">Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/scale-out/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" 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These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.</p></a><div class="menu-item-description"><p class="img-title">Robotic Aseptic Filling</p><p class="img-description">Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/robotic-fill/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li id="menu-item-20009" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20009"><a href="https://www.wuxibiologics.com/featured-platforms/continuous-manufacturing-bioprocess/">Continuous Manufacturing Process<p class="img-description">$Combining intensified perfusion 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menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-19910"><a href="https://www.wuxibiologics.com/company/">Company</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19911"><a href="https://www.wuxibiologics.com/company/#Vision_Mission">Vision & Mission</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19912"><a href="https://www.wuxibiologics.com/company/#Culture">Culture</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19917"><a href="https://www.wuxibiologics.com/company/#History_Awards">History & Awards</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19918"><a href="https://www.wuxibiologics.com/company/#Business_Ethics">Business Ethics</a></li> </ul> </li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-19908"><a href="https://www.wuxibiologics.com/leadership/">Leadership</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-19920"><a href="https://www.wuxibiologics.com/scientific-advisory-board/">Scientific Advisory Board</a></li> <li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-19922"><a href="https://www.wuxibiologics.com/locations-facilities/">Locations & Facilities</a></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom current-menu-ancestor menu-item-has-children menu-item-19921"><a>Services & Capabilities</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19923"><a>Production Systems</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19924"><a>Mammalian<p class="img-description">$Our expertise spans discovery, development, and cGMP manufacture of biologics from mammalian cell culture. Leveraging 6 discovery platforms, a top-tier CMC development team, and an extensive supply chain, we deliver seamless programs for all your biologics drug development needs.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19925"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/">Mammalian-Derived Product Services<p class="img-description">$A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.</p></a><div class="menu-item-description"><p class="img-title">Mammalian-Derived Product Services</p><p class="img-description">A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-intro menu-item menu-item-type-custom menu-item-object-custom menu-item-19926"><a>Product types we support:</a></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19927"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/monoclonal-antibodies/">Monoclonal Antibodies<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Monoclonal Antibodies</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/monoclonal-antibodies/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19928"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/bispecific-multispecific-antibodies/">Bispecific & Multispecific Antibodies<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Bispecific & Multispecific Antibodies</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/bispecific-multispecific-antibodies/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19929"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/fc-fusion-proteins/">Fc-Fusion Proteins<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Fc-Fusion Proteins</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/fc-fusion-proteins/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19930"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/antibody-fragments/">Antibody Fragments<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Antibody Fragments</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/antibody-fragments/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19931"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/recombinant-proteins-enzymes-cytokines/">Recombinant Proteins / Enzymes / Cytokines<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Recombinant Proteins / Enzymes / Cytokines</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/recombinant-proteins-enzymes-cytokines/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19932"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/viral-products/">Non-Vaccine Viral Products<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Non-Vaccine Viral Products</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/viral-products/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19933"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/antibody-drug-conjugate/">Antibody Drug Conjugates (ADCs)<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Antibody Drug Conjugates (ADCs)</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/antibody-drug-conjugate/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19934"><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/virus-like-products/">Virus-Like Particles (VLPs)<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Virus-Like Particles (VLPs)</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/mammalian-derived-product-services/virus-like-products/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19935"><a>Microbial<p class="img-description">$Comprehensive CMC development and cGMP manufacturing microbial fermentation platform. E. coli and yeast-based expression systems for the production of plasmid DNA and recombinant proteins.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19936"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/">Microbial-Derived Product Services<p class="img-description">$High quality, expert services for biologics produced from microbial fermentation.</p></a><div class="menu-item-description"><p class="img-title">Microbial-Derived Product Services</p><p class="img-description">High quality, expert services for biologics produced from microbial fermentation.</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-intro menu-item menu-item-type-custom menu-item-object-custom menu-item-19937"><a>Product types we support</a></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19938"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/antibody-fragments/">Antibody Fragments<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Antibody Fragments</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/antibody-fragments/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19939"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/enzyme_cytokine/">Enzymes / Cytokines<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Enzymes / Cytokines</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/enzyme_cytokine/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19940"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/plasmid-dna/">Plasmid DNA (pDNA)<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Plasmid DNA (pDNA)</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/plasmid-dna/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19941"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/virus-like-particles/">Virus-Like Particles (VLPs)<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">Virus-Like Particles (VLPs)</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/virus-like-particles/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="link-small menu-item menu-item-type-custom menu-item-object-custom menu-item-19942"><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/antibody-fragments/mrna/">RNA / mRNA<p class="img-description">$Discover information about the various drug development services we provide for this product type</p></a><div class="menu-item-description"><p class="img-title">RNA / mRNA</p><p class="img-description">Discover information about the various drug development services we provide for this product type</p><p><a href="https://www.wuxibiologics.com/production-systems/microbial-derived-product-services/antibody-fragments/mrna/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19944"><a>Capabilities</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19945"><a>Research<p class="img-description">$Integrated Discovery Platform From Concept to IND</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19946"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/">Integrated Discovery Service<p class="img-description">$Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.</p></a><div class="menu-item-description"><p class="img-title">Integrated Discovery Service</p><p class="img-description">Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19947"><a href="https://www.wuxibiologics.com/capabilities/protein-sciences/">Protein Sciences<p class="img-description">$Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.</p></a><div class="menu-item-description"><p class="img-title">Protein Sciences</p><p class="img-description">Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.</p><p><a href="https://www.wuxibiologics.com/capabilities/protein-sciences/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19948"><a>Development<p class="img-description">$Utilizing one of the world’s largest and most experienced development teams, we have the resources, technologies and expertise to drive your program toward IND and BLA in the most efficient and cost-effective manner.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19949"><a href="https://www.wuxibiologics.com/capabilities/protein-sciences/">Protein Sciences<p class="img-description">$We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.</p></a><div class="menu-item-description"><p class="img-title">Protein Sciences</p><p class="img-description">We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.</p><p><a href="https://www.wuxibiologics.com/capabilities/protein-sciences/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19950"><a href="https://www.wuxibiologics.com/capabilities/cell-line-engineering/">Cell Line Engineering<p class="img-description">$Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.</p></a><div class="menu-item-description"><p class="img-title">Cell Line Engineering</p><p class="img-description">Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.</p><p><a href="https://www.wuxibiologics.com/capabilities/cell-line-engineering/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19951"><a href="https://www.wuxibiologics.com/capabilities/analytical-development/">Analytical Sciences<p class="img-description">$Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.</p></a><div class="menu-item-description"><p class="img-title">Analytical Sciences</p><p class="img-description">Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.</p><p><a href="https://www.wuxibiologics.com/capabilities/analytical-development/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19952"><a href="https://www.wuxibiologics.com/capabilities/process-development-scale-up/">Process Development & Scale Up<p class="img-description">$Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.</p></a><div class="menu-item-description"><p class="img-title">Process Development & Scale Up</p><p class="img-description">Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.</p><p><a href="https://www.wuxibiologics.com/capabilities/process-development-scale-up/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19953"><a href="https://www.wuxibiologics.com/capabilities/drug-product-development/">Formulation & Drug Product Development<p class="img-description">$We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.</p></a><div class="menu-item-description"><p class="img-title">Formulation & Drug Product Development</p><p class="img-description">We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.</p><p><a href="https://www.wuxibiologics.com/capabilities/drug-product-development/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19954"><a href="https://www.wuxibiologics.com/capabilities/cell-banking/">Cell Banking & Characterization<p class="img-description">$Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.</p></a><div class="menu-item-description"><p class="img-title">Cell Banking & Characterization</p><p class="img-description">Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.</p><p><a href="https://www.wuxibiologics.com/capabilities/cell-banking/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19955"><a href="https://www.wuxibiologics.com/capabilities/biosafety-testing/#ViralClearanceStudies">Viral Clearance<p class="img-description">$Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.</p></a><div class="menu-item-description"><p class="img-title">Viral Clearance</p><p class="img-description">Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.</p><p><a href="https://www.wuxibiologics.com/capabilities/biosafety-testing/#ViralClearanceStudies" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19956"><a href="https://www.wuxibiologics.com/capabilities/regulatory-support/">Regulatory Support<p class="img-description">$Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.</p></a><div class="menu-item-description"><p class="img-title">Regulatory Support</p><p class="img-description">Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.</p><p><a href="https://www.wuxibiologics.com/capabilities/regulatory-support/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19957"><a>Manufacturing<p class="img-description">$Multiple state-of-the-art, premier quality cGMP clinical- and commercial-scale drug substance (DS) and drug product (DP) facilities across four countries for the production of a wide array of biologics from both mammalian and microbial expression systems.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-22252"><a href="https://www.wuxibiologics.com/capabilities/clinical-ds-manufacturing/">Clinical DS GMP Manufacturing<p class="img-description">$Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.</p></a><div class="menu-item-description"><p class="img-title">Clinical DS GMP Manufacturing</p><p class="img-description">Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.</p><p><a href="https://www.wuxibiologics.com/capabilities/clinical-ds-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-22253"><a href="https://www.wuxibiologics.com/capabilities/clinical-dp-manufacturing/">Clinical DP GMP Manufacturing<p class="img-description">$Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.</p></a><div class="menu-item-description"><p class="img-title">Clinical DP GMP Manufacturing</p><p class="img-description">Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.</p><p><a href="https://www.wuxibiologics.com/capabilities/clinical-dp-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19958"><a href="https://www.wuxibiologics.com/capabilities/commercial-ds-manufacturing/">Commercial DS GMP Manufacturing<p class="img-description">$We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.</p></a><div class="menu-item-description"><p class="img-title">Commercial DS GMP Manufacturing</p><p class="img-description">We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.</p><p><a href="https://www.wuxibiologics.com/capabilities/commercial-ds-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19959"><a href="https://www.wuxibiologics.com/capabilities/commercial-dp-manufacturing/">Commercial DP GMP Manufacturing<p class="img-description">$Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.</p></a><div class="menu-item-description"><p class="img-title">Commercial DP GMP Manufacturing</p><p class="img-description">Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.</p><p><a href="https://www.wuxibiologics.com/capabilities/commercial-dp-manufacturing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19960"><a>Testing<p class="img-description">$We provide extensive expertise for in-process, characterization, release and stability method development and testing either in support of our integrated biologics development platforms or as standalone projects. Our wide-range of analytical and biosafety testing Centers of Excellence and regulatory agency-approved quality control (QC) laboratories are the backbone of every service we provide our clients.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19961"><a href="https://www.wuxibiologics.com/capabilities/biosafety-testing/">Biosafety Testing<p class="img-description">$High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.</p></a><div class="menu-item-description"><p class="img-title">Biosafety Testing</p><p class="img-description">High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.</p><p><a href="https://www.wuxibiologics.com/capabilities/biosafety-testing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19962"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/">Analytical Testing<p class="img-description">$We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.</p></a><div class="menu-item-description"><p class="img-title">Analytical Testing</p><p class="img-description">We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.</p><p><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23361"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/bioassay-method-development-services/">Bioassay Method Development Services</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23362"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/product-characterization-services/">Product Characterization Services</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23363"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/routine-analytical-testing-services/">Routine Analytical Testing Services</a></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23364"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/bioassay-method-development-services/">Bioassay Method Development Services</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23365"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/product-characterization-services/">Product Characterization Service</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23366"><a href="https://www.wuxibiologics.com/capabilities/analytical-testing/routine-analytical-testing-services/">Routine Analytical Testing Services</a></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19963"><a href="https://www.wuxibiologics.com/capabilities/center-of-excellence/">Centers of Excellence (CoE)<p class="img-description">$Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.</p></a><div class="menu-item-description"><p class="img-title">Centers of Excellence (CoE)</p><p class="img-description">Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.</p><p><a href="https://www.wuxibiologics.com/capabilities/center-of-excellence/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19964"><a href="https://www.wuxibiologics.com/capabilities/global-quality-control/">Global Quality Control (QC)<p class="img-description">$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p></a><div class="menu-item-description"><p class="img-title">Global Quality Control (QC)</p><p class="img-description">Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p><p><a href="https://www.wuxibiologics.com/capabilities/global-quality-control/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom current-menu-ancestor menu-item-has-children menu-item-19965"><a>Quality</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom current-menu-ancestor current-menu-parent menu-item-has-children menu-item-19966"><a>Quality & Regulatory<p class="img-description">$We provide world-class quality systems, harmonized across our global manufacturing sites and approved by multiple global regulatory agencies, including the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANVISA and Health Canada for the production and testing of a wide array of biologics.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19967"><a href="https://www.wuxibiologics.com/quality/quality-compliance/">Global Compliance<p class="img-description">$Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.</p></a><div class="menu-item-description"><p class="img-title">Global Compliance</p><p class="img-description">Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.</p><p><a href="https://www.wuxibiologics.com/quality/quality-compliance/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom current-menu-item menu-item-19968"><a href="https://www.wuxibiologics.com/quality/quality-assurance/" aria-current="page">Quality Assurance<p class="img-description">$Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.</p></a><div class="menu-item-description"><p class="img-title">Quality Assurance</p><p class="img-description">Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.</p><p><a href="https://www.wuxibiologics.com/quality/quality-assurance/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19969"><a href="https://www.wuxibiologics.com/quality/quality-control/">Quality Control<p class="img-description">$Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p></a><div class="menu-item-description"><p class="img-title">Quality Control</p><p class="img-description">Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).</p><p><a href="https://www.wuxibiologics.com/quality/quality-control/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19970"><a href="https://www.wuxibiologics.com/quality/regulatory-affair/">Regulatory Affairs<p class="img-description">$Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.</p></a><div class="menu-item-description"><p class="img-title">Regulatory Affairs</p><p class="img-description">Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.</p><p><a href="https://www.wuxibiologics.com/quality/regulatory-affair/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19971"><a>Featured Platforms</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19972"><a>Integrated Platforms<p class="img-description">$Comprehensive, high-quality, end-to-end solutions driving efficiency, decreasing time to clinic and reducing project risks from concept to commercialization.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19973"><a href="https://www.wuxibiologics.com/featured-platforms/target-to-lead/">Target to Lead<p class="img-description">$Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.</p></a><div class="menu-item-description"><p class="img-title">Target to Lead</p><p class="img-description">Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/target-to-lead/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19974"><a href="https://www.wuxibiologics.com/featured-platforms/dna-to-ind/">DNA to IND<p class="img-description">$Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.</p></a><div class="menu-item-description"><p class="img-title">DNA to IND</p><p class="img-description">Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/dna-to-ind/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19975"><a href="https://www.wuxibiologics.com/featured-platforms/ind-to-bla/">IND to BLA<p class="img-description">$Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.</p></a><div class="menu-item-description"><p class="img-title">IND to BLA</p><p class="img-description">Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/ind-to-bla/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19976"><a>Discovery Technologies<p class="img-description">$A full spectrum of discovery services and technologies for the engineering, generation, characterization, optimization and selection of high-potency novel antibody therapeutics.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19977"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#wuxibody">Bispecific & Multispecific Antibodies – WuXiBody™<p class="img-description">$The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.</p></a><div class="menu-item-description"><p class="img-title">Bispecific & Multispecific Antibodies - WuXiBody™</p><p class="img-description">The WuXiBody™ platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#wuxibody" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19978"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#hybridoma">Advanced Hybridoma Platform – WuXiHybrid™<p class="img-description">$Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.</p></a><div class="menu-item-description"><p class="img-title">Advanced Hybridoma Platform - WuXiHybrid™</p><p class="img-description">Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#hybridoma" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19979"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#phage">Naive Phage Display Library – WuXiLiAb™<p class="img-description">$Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.</p></a><div class="menu-item-description"><p class="img-title">Naive Phage Display Library - WuXiLiAb™</p><p class="img-description">Offering high-quality phage display library construction and customized library selection and screening services via our WuXiLiAb® human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#phage" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19980"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#sdarbody">VHH-based Multispecific Antibody Platform – SDARBody™<p class="img-description">$Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.</p></a><div class="menu-item-description"><p class="img-title">VHH-based Multispecific Antibody Platform - SDARBody™</p><p class="img-description">Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#sdarbody" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19981"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#skybody">ScFv-based BsAb & MsAb Antibody Platform – SKYBody™<p class="img-description">$An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.</p></a><div class="menu-item-description"><p class="img-title">ScFv-based BsAb & MsAb Antibody Platform - SKYBody™</p><p class="img-description">An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/bispecific-antibody/#skybody" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19982"><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#single-b-cell-screening">VAST-B Single B-Cell Antibody Discovery Platform<p class="img-description">$An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.</p></a><div class="menu-item-description"><p class="img-title">VAST-B Single B-Cell Antibody Discovery Platform</p><p class="img-description">An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon® technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.</p><p><a href="https://www.wuxibiologics.com/capabilities/integrated-discovery/mabs/#single-b-cell-screening" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-19998"><a href="#">Development Technologies<p class="img-description">$Cutting-edge bioprocessing platforms and technologies designed to enable high-quality biologics to enter clinical trials faster, more efficiently and more cost-effectively.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-19999"><a href="https://www.wuxibiologics.com/featured-platforms/wuxiui/">Ultra-Intensified Fed-batch platform – WuXiUI™<p class="img-description">$Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.</p></a><div class="menu-item-description"><p class="img-title">Ultra-Intensified Fed-batch platform - WuXiUI™</p><p class="img-description">Ultra-intensified fed-batch bioprocessing platform utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxiui/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20000"><a href="https://www.wuxibiologics.com/featured-platforms/wuxian/">Rapid Research Material Generation – WuXian™<p class="img-description">$Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.</p></a><div class="menu-item-description"><p class="img-title">Rapid Research Material Generation - WuXian™</p><p class="img-description">Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxian/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20001"><a href="https://www.wuxibiologics.com/featured-platforms/wuxia/">Cell Line Development – WuXia™<p class="img-description">$Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.</p></a><div class="menu-item-description"><p class="img-title">Cell Line Development - WuXia™</p><p class="img-description">Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxia/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20002"><a href="https://www.wuxibiologics.com/featured-platforms/wuxiup/">Continuous Bioprocessing – WuXiUP™<p class="img-description">$This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.</p></a><div class="menu-item-description"><p class="img-title">Continuous Bioprocessing - WuXiUP™</p><p class="img-description">This ultra-high productivity continuous bioprocessing platform, achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxiup/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20003"><a href="https://wuxixdc.com/technologies-wuxidar4-adcs/">ADC Development Platform – WuXiDAR4™<p class="img-description">$Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.</p></a><div class="menu-item-description"><p class="img-title">ADC Development Platform - WuXiDAR4™</p><p class="img-description">Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.</p><p><a href="https://wuxixdc.com/technologies-wuxidar4-adcs/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20004"><a href="https://www.wuxibiologics.com/featured-platforms/wuxihigh/#wuxi-high-concentration">High Concentration & HTP DP Platform – WuXiHigh™<p class="img-description">$Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.</p></a><div class="menu-item-description"><p class="img-title">High Concentration & HTP DP Platform - WuXiHigh™</p><p class="img-description">Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/wuxihigh/#wuxi-high-concentration" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-20005"><a>Manufacturing Technologies<p class="img-description">$Advanced biomanufacturing platforms empower our global healthcare partners to deliver biologics to the clinic and on to the market for the benefit of patients worldwide.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20006"><a href="https://www.wuxibiologics.com/featured-platforms/single-use-bioreactors/">Single-Use Bioreactors<p class="img-description">$We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.</p></a><div class="menu-item-description"><p class="img-title">Single-Use Bioreactors</p><p class="img-description">We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/single-use-bioreactors/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20007"><a href="https://www.wuxibiologics.com/featured-platforms/scale-out/">Scale-Out Biomanufacturing<p class="img-description">$Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.</p></a><div class="menu-item-description"><p class="img-title">Scale-Out Biomanufacturing</p><p class="img-description">Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/scale-out/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20008"><a href="https://www.wuxibiologics.com/featured-platforms/robotic-fill/">Robotic Aseptic Filling<p class="img-description">$Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.</p></a><div class="menu-item-description"><p class="img-title">Robotic Aseptic Filling</p><p class="img-description">Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/robotic-fill/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20009"><a href="https://www.wuxibiologics.com/featured-platforms/continuous-manufacturing-bioprocess/">Continuous Manufacturing Process<p class="img-description">$Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.</p></a><div class="menu-item-description"><p class="img-title">Continuous Manufacturing Process</p><p class="img-description">Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/continuous-manufacturing-bioprocess/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-23135"><a>Animal Health Technologies<p class="img-description">$One-stop solution for superior animal health outcomes.</p></a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-23136"><a href="https://www.wuxibiologics.com/featured-platforms/animal-health/">Animal Health Technologies<p class="img-description">$We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.</p></a><div class="menu-item-description"><p class="img-title">Animal Health Technologies</p><p class="img-description">We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.</p><p><a href="https://www.wuxibiologics.com/featured-platforms/animal-health/" class="d-flex align-items-center">Learn more <svg height="12" viewBox="0 0 18 11" style="margin-left:5px;"><defs><style>.cls-1{fill:#555;fill-rule:evenodd;}</style></defs><path class="cls-1" d="M379.5,368.69h17.17v.74H379.5Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.08,363.5,397.5,369l-.5.51L391.58,364Z" transform="translate(-379.5 -363.5)"/><path class="cls-1" d="M392.18,374.5l5.21-5.31-.49-.5L391.69,374Z" transform="translate(-379.5 -363.5)"/></svg></a></p></li> </ul> </li> </ul> </li> </ul> </li> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-21715"><a href="https://www.wuxibiologics.com/sustainability">Sustainability</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-20012"><a href="https://www.wuxibiologics.com/sustainability/">Sustainability</a> <ul class="sub-menu"> <li class="menu-item menu-item-type-custom menu-item-object-custom menu-item-20013"><a 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</script><section id="main-content"> <div id="solutions_children"> <div class="solutions_children_main"> <div class="d-flex web_route"> <div><a href="/services-capabilities/">Services & Capabilities </a></div> <div><a href="/quality/">Quality</a></div> </div> <h1 class="solutions_children_title">Quality Assurance</h1> <div class="solutions_children_text" data-wow-delay="0.5s" style="visibility: visible; animation-delay: 0.5s; animation-name: fadeInUp;"><p></p> <p> <p>We have established a global quality system, <a href="https://www.wuxibiologics.com/quality-control-qc/">quality control</a> and operational systems that meet or exceed worldwide regulatory standards from the U.S. FDA, EMA, NMPA and other major regulatory agencies. Starting with our Chief Executive Officer, our commitment to quality is ingrained in our company culture and our employees and we have harmonized our quality assurance (QA) and quality management system across all sites around the world for the clinical or commercial production of biologics and vaccines drug substance and drug product. </p> <p> </p> <p>Our commitment to quality is one of our <a href="https://www.wuxibiologics.com/wuxi-biologics-difference-video/">pillars of success</a> for enabling our clients to bring novel biotherapeutics and vaccines into the clinic and beyond. To learn more, see our <a href="https://www.wuxibiologics.com/wuxi-biologics-difference-premier-world-class-quality/">video outlining our premier, world-class quality system</a>.</p> <p> </p> <p><img fetchpriority="high" decoding="async" class="wp-image-8496 aligncenter" src="https://www.wuxibiologics.com/wp-content/uploads/Quality-Assurance-graphics-080222.jpg" alt="" width="809" height="360" /></p> </p> <p></p> </div> <div class="SolutionsThird_quality_nav"> <div class="qualityControl_nav wow fadeInUp"><h2><strong>Our Quality Track Record</strong></h2> </div> </div> <div class="SolutionsThird_quality_nav"> <div class="qualityControl_nav wow fadeInUp" data-wow-delay="0.5s" style="visibility: visible; animation-delay: 0.5s; animation-name: fadeInUp;"> <ul class="row"> <li class="col-md-4"> <a class="d-flex align-items-center justify-content-center"><span>Site Certifications</span></a> </li> <li class="col-md-4"> <a class="d-flex align-items-center justify-content-center"><span>Client Quality Audits</span></a> </li> <li class="col-md-4"> <a class="d-flex align-items-center justify-content-center"><span>Regulatory Agency Inspections</span></a> </li> <li class="col-md-4"> <a class="d-flex align-items-center justify-content-center"><span>Product Licenses and EUAs</span></a> </li> <li class="col-md-4"> <a class="d-flex align-items-center justify-content-center"><span>IND Filings</span></a> </li> </ul> </div> <div class="qualityControl_nav_con"> <div class="qualityControl_nav_con_list"> <div class="solutions_children_text"> <p><span style="font-size: 12pt;"><strong>All of our GMP manufacturing operations adhere to global regulations and guidelines including those from the FDA, EMA and NMPA. We currently have 15 different drug substance and drug product manufacturing facilities and quality control testing laboratories that have received GMP certifications.</strong></span></p> <p> </p> </div> <ul class="development_list"> <li style="background-color: #0068b7"> <a class="box"> <div class="text"> <div class="title"> <div class="title">Facilities Certified for GMP Manufacturing</div> <div class="text_s">15</div> </div> </div> <div class="img bg_cover" style="background-image: url()"></div> </a></li> </ul> </div> <div class="qualityControl_nav_con_list"> <div class="solutions_children_text"> <p><span style="font-size: 12pt;"><strong>We have passed over 1400 client GMP / quality audits and continue to strive and meet their stringent quality expectations. </strong></span></p> <p> </p> </div> <ul class="development_list"> <li style="background-color: #38beef"> <a class="box"> <div class="text"> <div class="title"> <div class="title">Successful Global Client Audits</div> <div class="text_s">1400+</div> </div> </div> <div class="img bg_cover" style="background-image: url()"></div> </a></li> </ul> </div> <div class="qualityControl_nav_con_list"> <div class="solutions_children_text"> <p><span style="font-size: 12pt;"><strong>We have passed 37 inspections from multiple global regulatory agencies including the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.</strong></span></p> <p> </p> </div> <ul class="development_list"> <li style="background-color: #9fb92e"> <a class="box"> <div class="text"> <div class="title"> <div class="title">Successful Regulatory Inspections from 12 different Global Agencies</div> <div class="text_s">37</div> </div> </div> <div class="img bg_cover" style="background-image: url()"></div> </a></li> </ul> </div> <div class="qualityControl_nav_con_list"> <div class="solutions_children_text"> <p><strong><span style="font-size: 12pt;">We have enabled our clients to successfully obtain 67 product license approvals and EUAs related to BLA / MAA / EUA filings for over 16 products and from over 35 different regulatory agencies. </span></strong></p> <p> </p> </div> <ul class="development_list"> <li style="background-color: #fdd000"> <a class="box"> <div class="text"> <div class="title"> <div class="title">Client Product License Approvals and EUAs</div> <div class="text_s">67</div> </div> </div> <div class="img bg_cover" style="background-image: url()"></div> </a></li> </ul> </div> <div class="qualityControl_nav_con_list"> <div class="solutions_children_text"> <p><strong><span style="font-size: 12pt;">Using our integrated <a href="https://www.wuxibiologics.com/mammalian/dna-to-ind/">DNA to IND biologics development and manufacturing platforms</a>, we have successfully helped our clients from all around the world to successfully file over 550 Investigational New Drug (IND) applications since 2015.</span></strong></p> <p> </p> </div> <ul class="development_list"> <li style="background-color: #00a33e"> <a class="box"> <div class="text"> <div class="title"> <div class="title">Successful Client INDs Filings</div> <div class="text_s">550+</div> </div> </div> <div class="img bg_cover" style="background-image: url()"></div> </a></li> </ul> </div> </div> </div> <div class="solutions_children_text wow fadeInUp"><div data-wow-delay="0.5s"><strong><span style="font-size: 18pt;">Keys to Meeting Client Quality Assurance Expectations</span></strong></div> <div data-wow-delay="0.5s"> </div> <div data-wow-delay="0.5s">WuXi Biologics utilize ALCOA+ data integrity principles, extensive employee training programs and an unwavering commitment to protecting our client’s IP as key components in our ability to provide a premier, world-class quality system that will enable our clients to provide novel biologics and vaccines for the benefit of patients worldwide.</div> <div data-wow-delay="0.5s"> </div> <div data-wow-delay="0.5s"><img decoding="async" class="wp-image-8508 aligncenter" src="https://www.wuxibiologics.com/wp-content/uploads/Quality-Assurance-graphics-0802222.jpg" alt="" width="771" height="343" /></div> <div data-wow-delay="0.5s"> </div> <div data-wow-delay="0.5s"><img decoding="async" class="wp-image-8799 aligncenter" src="https://www.wuxibiologics.com/wp-content/uploads/Quality-Assurance-graphics-0802226-1.jpg" alt="" width="785" height="349" /></div> <div data-wow-delay="0.5s"> </div> <div data-wow-delay="0.5s"> <div id="attachment_8513" style="width: 795px" class="wp-caption aligncenter"><img aria-describedby="caption-attachment-8513" decoding="async" class=" wp-image-8513" src="https://www.wuxibiologics.com/wp-content/uploads/Quality-Assurance-graphics-0802225-1.jpg" alt="" width="785" height="349" /><p id="caption-attachment-8513" class="wp-caption-text">Protecting our clients IP is a cornerstone of our quality programs and company culture.</p></div> </div> <div data-wow-delay="0.5s"> </div> <div data-wow-delay="0.5s"> </div> <hr /> </div> </div> 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