GMP Manufacturing Capabilities & Quality Compliance

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <noscript><style>form.antibot * :not(.antibot-message) { display: none !important; }</style> </noscript><meta name="applicable-device" content="pc,mobile" /> <meta name="description" content="Learn about GMP manufacturing capabilities at Bio-Techne, including GMP-grade proteins and small molecules plus regulatory support and quality compliance." /> <link rel="canonical" href="https://www.bio-techne.com/gmp-products/gmp-capabilities" /> <meta property="og:site_name" content="Bio-Techne" /> <meta property="og:type" content="website" /> <meta property="og:url" content="https://www.bio-techne.com/gmp-products/gmp-capabilities" /> <meta property="og:image" content="https://resources.bio-techne.com/bio-techne-assets/images/brands/bio-techne-og.png" /> <meta name="published-date" content="1612900350" /> <meta name="revision-date" content="1725478962" /> <meta name="Generator" content="Drupal 10 (https://www.drupal.org)" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@graph": [ { "@type": "WebPage", "@id": "https://www.bio-techne.com/gmp-products/gmp-capabilities", "breadcrumb": { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://www.bio-techne.com/" }, { "@type": "ListItem", "position": 2, "name": "GMP Products", "item": "https://www.bio-techne.com/gmp-products" } ] } } ] }</script> <meta http-equiv="x-dns-prefetch-control" content="on" /> <script type="application/ld+json">{ "@context":"https:\/\/schema.org", "@type":"FAQPage", "mainEntity":[{ "@type":"Question", "name":"How do you ensure the raw materials you use in your manufacturing are appropriate to make products that can be used for ex vivo manufacturing?", "acceptedAnswer":{ "@type":"Answer", "text":"Raw materials are sourced from qualified suppliers with supplier qualification and monitoring systems in place. We also perform risk assessments for critical raw materials used in GMP processes every three years. This includes visual inspection of raw materials with documentation tracking of the Certificate of Analysis (CoA), Certificate of Origin (CoO), TSE/BSE statements, and animal-free statements, if applicable. Identity confirmation is performed for some critical raw materials before accepting. For animal-derived materials, we always source from countries considered to be a negligible or controlled BSE risk."}},{ "@type":"Question", "name":"What advice would you give to cell therapy developers when sourcing their raw materials?", "acceptedAnswer":{ "@type":"Answer", "text":"We advise cell therapy developers to always source raw materials from USP-grade or GMP-grade if possible. Our GMP-grade products are manufactured and tested according to applicable standards in Unites States Pharmacopeia (USP) Section <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products, and European Pharmacopeia (Ph. Eur.) General Chapter 5.2.12 Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products. A supplier should have a certified quality management system (QMS), such as ISO 9001:2015 or ISO13485: 2016. This means the supplier has been independently audited and has policies and processes in place designed to meet the needs of their customers. Suppliers of these raw materials should be further qualified and monitored by questionnaire, performance of on time delivery, SCARs, and other auditing activities. The Certificate of Analysis, Certificate of Origin and other related documents should be received from each supplier and kept as development and manufacturing records. Developers should have early discussions about quality and supply agreements with suppliers to avoid surprises as you progress into production. A manufacturer should have the ability to scale up and meet your future needs in order to avoid late-stage changes that might require costly revalidation. Secondary suppliers should be identified early as well. Raw materials may look identical on a Certificate of Analysis but could behave differently in your biological system. It should never be assumed that you can easily switch between suppliers for a given raw material. Validation studies are required to show equivalency between raw materials from different suppliers. "}},{ "@type":"Question", "name":"How do you ensure a smooth transition from research use only (RUO) to Good Manufacturing Practice (GMP)? ", "acceptedAnswer":{ "@type":"Answer", "text":"If the same vendor is used, ideally, the physical characteristics of RUO-grade raw materials would be the same as GMP-grade. They would differ only in robust documentation, such as Quality Assurance personnel performing final review and approval of batch documentation, and formal validation conducted for GMP products. There should also be extensive safety testing of raw materials that might come into contact with patients. It is fair to ask a vendor whether the manufacturing processes are the same for RUO and GMP raw materials. If clinical applications are the goal, it is suggested that the switch to GMP be made early. Even during preclinical stages if possible. It is far easier to do equivalency testing early in product development than during later stages when changes can be costly and time-consuming. Choosing a vendor with experience can also be advantageous. This can mean having a good understanding of quality management systems, protein biochemistry, and analytical testing methods. In addition, experience in regulatory matters is key. An experienced vendor can help when navigating changing regulatory landscapes. Availability of Drug Master Files (DMF) that contain detailed information about the raw material can assist regulatory authorities and ease investigational new drug (IND) applications. If possible, audits of vendor facilities should be conducted, and virtual audits should be made available for those that canít be done in person. The relationship between vendor and customer needs to be a partnership, and experience counts. A minimum of three consecutive lots are manufactured, tested, and released in accordance with approved standard operating procedures to meet pre-determined acceptance criteria. (The Quality Control department is responsible for final review and approval of RUO products). For products that were developed with RUO raw materials, there may have been modifications in the manufacturing process and/or final product testing which are applicable to the GMP product. In this case, it is advisable that the GMP product is used for any ex vivo clinical studies."}},{ "@type":"Question", "name":"Cell and gene therapy manufacturers need to bridge batches (lot-to-lot consistency, GMP testing against master lot). How can you ensure lot-to-lot consistency and reduce variability?", "acceptedAnswer":{ "@type":"Answer", "text":"Cytokines and growth factors are made in biological systems and can be susceptible to variability. They should only be released to market after successful manufacturing of many consecutive batches that have passed stringent specifications. This builds a solid foundation for future manufacturing consistency and reliability. Manufacturing processes must be controlled with rigorously documented SOPs and highly trained staff. This information should be made available during audit. It is fair to request data from several lots in order to assess a vendorís ability to make proteins reproducibly. Ideally, materials from multiple lots should be obtained so they can be tested for consistency in your system. At Bio-Techne, we maintain master control lots. Each new bulk lot is compared against the master lot prior to release to market. This reduces variability and ensures consistent product performance."}} ]} </script> <meta http-equiv="x-ua-compatible" content="ie=edge" /> <link rel="alternate" hreflang="en" href="https://www.bio-techne.com/gmp-products/gmp-capabilities" /> <link rel="alternate" hreflang="zh-hans" href="https://www.bio-techne.com/cn/gmp-products/gmp-capabilities" /> <link rel="icon" href="/themes/custom/bio_techne_global/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="preconnect" href="https://resources.bio-techne.com" /> <link rel="preconnect" href="https://resources.tocris.com" /> <link rel="preconnect" href="https://i.icomoon.io" /> <link rel="preconnect" href="https://cdn.icomoon.io" /> <link rel="dns-prefetch" href="https://connect.facebook.net" /> <link rel="dns-prefetch" href="https://resources.bio-techne.com" /> <link rel="dns-prefetch" href="https://snap.licdn.com" /> <link rel="dns-prefetch" href="https://www.google-analytics.com" /> <link rel="dns-prefetch" 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class="col sub-menu-wrapper"> <div class="sub-menu-header"> Product & Instrument Tools<span class="icon-keyboard_arrow_down submenu-caret"></span> <hr/> <div class="menu-children-wrap sub-menu-box"> <a href="/resources/cofa-finder-tool" class="dropdown-item text-wrap" data-drupal-link-system-path="resources/cofa-finder-tool">Certificate of Analysis (COA) Finder Tool</a> <a href="/resources/calculators" class="dropdown-item text-wrap" data-drupal-link-system-path="node/7416">Calculators</a> <a href="/resources/flow-cytometry-panel-builder" class="dropdown-item text-wrap" data-drupal-link-system-path="node/8821">Flow Cytometry Panel Builder</a> <a href="/luminex-assay-customization-tool" class="dropdown-item text-wrap" data-drupal-link-system-path="luminex-assay-customization-tool">Luminex Assay Customization Tool</a> <a href="/resources/product-insert-lookup-tool" class="dropdown-item text-wrap" data-drupal-link-system-path="resources/product-insert-lookup-tool">Product Insert Lookup 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paragraph--type--hero-banner paragraph--view-mode--full paragraph-background-color--dark"> <div class="banner_background_image no-lazy-load" style="background: linear-gradient(to top, rgba(0, 0, 0, 0.0) 0%, rgba(0, 0, 0, 0.90) 100%), url('https://resources.bio-techne.com/bio-techne-assets/images/banners/bt-gmp-capabilities-hero-banner-1500x340-v2.jpg'); background-position: top center; background-repeat: no-repeat; background-size: cover;"> <div> <div class="paragraph paragraph--type--h1-2-2-text-to-media paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--50-50"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:h1_2_2_text_to_media:field_indv_h1"> <div><h1>GMP Capabilities - Facilities, Quality, & Regulatory</h1></div> </div> <div class="field_block:paragraph:h1_2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Certifications for Our Global Manufacturing Facilities, Quality and Regulatory Compliance, and Flexibility for Custom Services.</p></div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:h1_2_2_text_to_media:field_indv_media"> <div> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/bt-gmp-capabilities-instrument-hero.png" alt="GMP Capabilities Hero Instrument" fetchpriority="high" > </div> </div> </div> </div> </div> </div> </div> </div> </div> </section> </div> </div> </header> </div> <div id="main" class="container-fluid container-wide"> <div class="row"> <div class="col-md-12"> <div> <div id="block-bio-techne-global-breadcrumbs" class="system_breadcrumb_block"> <nav role="navigation" aria-labelledby="system-breadcrumb"> <h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2> <ol> <li> <a href="/">Home</a> </li> <li> <a href="/gmp-products">GMP Products</a> </li> <li> GMP Capabilities </li> </ol> </nav> </div> </div> </div> </div> <main> <section class="section"> <div> <div id="block-bio-techne-global-content" class="system_main_block"> <article> <div> <div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h2>Good Manufacturing Practices in Cell & Gene Therapy</h2></div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-2-text-to-media mb-4 paragraph--view-mode--default"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--50-50"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>At Bio-Techne, we recognize the promise of cell and gene therapy as well as the increasing demand for GMP-grade raw materials and services. Although the challenges surrounding this industry are numerous, we can reduce your manufacturing risks by providing industry-leading quality, consistency, reliability, and capacity. You can advance seamlessly into regulatory agency submissions with our regulatory affairs team as a partner.</p> <h3>Table of Contents </h3> <ul> <li><a href="#Streamline">Streamlining Transition</a></li> <li><a href="#Custom">Custom Services</a></li> <li><a href="#Animal">Animal-Free Manufacturing</a></li> <li><a href="#GMP">Our GMP Facilities</a></li> <li><a href="#FAQ">FAQs</a></li> <li><a href="#Form">Inquire About GMP</a></li> </ul></div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:2_2_text_to_media:field_indv_media"> <div> <article> <div class="youtube-video-place"> <lite-youtube videoid="H6w_32k51RQ" params="rel=0" style="background-image: url('https://img.youtube.com/vi/H6w_32k51RQ/maxresdefault.jpg');"> <a href="https://www.youtube.com/embed/H6w_32k51RQ?autoplay=1" class="lty-playbtn" title="Bio-Techne's GMP Manufacturing Facilities - Invested In the Next Generation of Therapeutics"> <span class="lyt-visually-hidden">Bio-Techne's GMP Manufacturing Facilities - Invested In the Next Generation of Therapeutics</span> </a> </lite-youtube> </div> </article> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><p>Our GMP products are intended for use as ancillary or raw materials in GMP manufacturing of investigational or marketed clinical products, such as cell therapy, gene therapy, tissue-engineered products, combination products, or other Advanced Therapy Medicinal Products (ATMP). They are not therapeutic products or excipients and are not suitable for direct administration to humans. For simplicity, we use the term GMP to cover both our products and our manufacturing processes.</p> <p>We strive to ensure lot-to-lot consistency and minimize supply chain roadblocks that can cause expensive manufacturing process delays. We serve clients from around the world, and we guarantee the confidentiality of every contract.</p></div> </div> </div> <div> <div class="paragraph paragraph--type--individual-button mb-4 paragraph--view-mode--default w-100"> <div class="row"> <div class="col"> <a href="/research-areas/cell-and-gene-therapy" class="btn btn-primary" type="link" > Find What You Need for C&GT </a> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-1-text-to-media mb-4 paragraph--view-mode--default p-3"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--75-25"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_header_2_global"> <div><h2>GMP Quality Compliance</h2></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_lg_sngl_frmtd_text_global"> <div><p>Our Quality Team includes more than 120 employees in quality and regulatory roles worldwide. We ensure compliance with all relevant guidelines from governing authorities.</p> <p>Our team oversees:</p> <ul> <li>Personnel training programs</li> <li>Facility maintenance and safety programs</li> <li>Validation of equipment and equipment calibration schedules</li> <li>Raw materials inspection, testing, and tracing</li> <li>Supplier qualification</li> <li>Material review board oversight of variances</li> </ul> <p>Our QA team also oversees documentation covering processes and process changes, product change notifications, test methods, individual SOPs and batch records, lot-specific certificates of analysis, and certificates of origin. We perform a full QA review of all batch and bottling records before any material is shipped.</p> <p>Each of our facilities is regularly audited by clients. We are experienced in both on-site and virtual audits.</p></div> </div> <div class="field_block:paragraph:3_1_text_to_media:field_call_to_action_global"> <a href="#Form" class="btn btn-primary" type="link"> Request A GMP Quality Consultation </a> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:3_1_text_to_media:field_indv_media"> <div> <a href="https://www.bio-techne.com#Form" title="Request A GMP Quality Consultation" target="_self" > <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-quality-compliance.png" alt="Quality compliance" loading="lazy" > </a> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--_-3-media-to-text paragraph--view-mode--default mb-4"> <div class="container-fluid container-wide"> <div class="layout layout--twocol-section layout--twocol-section--25-75"> <div class="layout__region layout__region--first"> <div class="hero-content-wrap"> <div class="field_block:paragraph:1_3_media_to_text:field_indv_media"> <div> <a href="https://www.bio-techne.com/gmp-products/ruo-to-gmp" title="Streamline Your Transition to GMP" target="_self" > <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-lab.png" alt="CGT lab" loading="lazy" > </a> </div> </div> </div> </div> <div class="layout__region layout__region--second"> <div class="hero-content-wrap"> <div class="field_block:paragraph:1_3_media_to_text:field_header_2_global"> <div><h2>Transitioning Research to GMP</h2></div> </div> <div class="field_block:paragraph:1_3_media_to_text:field_lg_sngl_frmtd_text_global"> <div><p><a name="Streamline"></a>As you advance from discovery into process development and clinical manufacturing, we make the transition as efficient and seamless as possible. Our GMP materials are based on our research-grade products wherever possible. If GMP-grade materials are not available, our Custom Services team will work with you to convert RUO materials into products appropriate for manufacturing use. We have recently developed an intermediate tier of small molecules to meet the rapidly increasing needs of the cell therapy industry.</p> <p>Our Ancillary Materials Grade Small Molecules are certified animal-free and supported by enhanced QC testing, a more detailed QA review, and accompanying documentation. Incorporation of GMP or AM-grade raw materials early in your program will simplify your clinical transition. Our diligence with quality control ensures that you can move seamlessly into regulatory agency submissions without disrupting your process.</p></div> </div> <div class="field_block:paragraph:1_3_media_to_text:field_call_to_action_global"> <a href="/gmp-products/ruo-to-gmp" class="btn btn-primary" type="link"> Streamline Your Transition to GMP </a> </div> </div> </div> </div> </div> </div> </div> <div> <div class="thin-banner banner_wrapper"> <div class="banner-dark"> <div> <div><h2>Transition to the Clinic with GMP Proteins</h2></div> <a href="/gmp-products/gmp-proteins/sample-gmp-proteins" > <button type="button" class="btn btn-primary"> Request GMP Protein Sample </button> </a> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><h2><a name="Custom"></a>GMP Custom Services</h2> <p>We understand that cell manufacturing processes are optimized for individual outcomes. We will work with you to develop and deliver GMP raw materials and services that meet your specifications. We can provide customized vialing as well as construct design, formulation, and quality control analysis. With a dedicated project manager, our expert scientists, quality assurance team, and world-class technical support, we will deliver solutions exactly tailored to bring you success faster and more economically.</p></div> </div> </div> <div> <div class="paragraph paragraph--type--card-paragraph paragraph--view-mode--default card-para-default"> <div class="row card_row"> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <div class="teaser-card-image-crop mb-3"> <img loading="lazy" class="card-background-image card-img-top" src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-benefits-background.png" /> </div> <div class="card-foreground-image"> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-benefits-v2.png" alt="Stem cell" loading="lazy" > </div> <h3 class="card_title_htag"> <div><h2>Benefits of Custom Services from Bio-Techne...</h2></div> </h3> <div class="card_description flex-grow-1"> <div><ul> <li>Scientific expertise and dedicated project managers</li> <li>Performance consistency</li> <li>Timeliness of supply</li> <li>Regulatory support</li> <li>ISO-certified Quality Management System and FDA registered</li> <li>Confidentiality</li> </ul></div> </div> <div class="card-bottom-link"></div> </div> </div> </div> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <div class="teaser-card-image-crop mb-3"> <img loading="lazy" class="card-background-image card-img-top" src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-expect-background.png" /> </div> <div class="card-foreground-image"> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-expect.png" alt="Genome engineering" loading="lazy" > </div> <h3 class="card_title_htag"> <div><h2>What You Can Expect...</h2></div> </h3> <div class="card_description flex-grow-1"> <div><ul> <li>Consultation with our experts to define the need</li> <li>Refining the project specifics, milestones, and deliverables</li> <li>Regular project updates</li> </ul></div> </div> <div class="card-bottom-link"></div> </div> </div> </div> <div class="col-md-4"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <div class="teaser-card-image-crop mb-3"> <img loading="lazy" class="card-background-image card-img-top" src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-custom-background.png" /> </div> <div class="card-foreground-image"> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-gmp-capabilities-custom-v3.png" alt="Flow cytometry" loading="lazy" > </div> <h3 class="card_title_htag"> <div><h2>Our Custom Services</h2></div> </h3> <div class="card_description flex-grow-1"> <div><ul><li><a href="/services/custom-protein-services" target="_self">Custom Protein Services</a></li><li><a href="https://www.rndsystems.com/services/gmp-antibody-services" target="_blank">GMP Antibody Services</a></li><li><a href="https://www.rndsystems.com/services/custom-chemistry" target="_blank">Chemistry Services</a></li><li><a href="/services/custom-cell-and-gene-therapy-services" target="_self">Custom Cell Culture Manufacturing and Services</a></li><li><a href="/services/custom-cell-and-gene-therapy-services" target="_self">Custom Services for Cell & Gene Therapies</a></li><li><a href="https://www.rndsystems.com/products/gmp-cell-and-process-development" target="_blank">GMP Cell Manufacturing and Process Development</a></li><li><a href="/services/custom-formulation" target="_self">Custom Formulation Services</a></li><li><a href="/services/custom-protein-services" target="_self">Custom Vialing of GMP Cytokines by Mass and Activity</a></li></ul></div> </div> <div class="card-bottom-link"></div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--individual-button mb-4 paragraph--view-mode--default w-100"> <div class="row"> <div class="col"> <a href="#Form" class="btn btn-primary" type="link" > Inquire About Our GMP Capabilities </a> </div> </div> </div> </div> <div> <div class="thin-banner banner_wrapper"> <div class="banner-dark"> <div> <div><h2>Bring More Flexibility to Your T Cell Activation Process</h2></div> <a href="/gmp-products/gmp-antibodies" > <button type="button" class="btn btn-primary"> Request GMP Antibody Sample </button> </a> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><h2><a name="Animal"></a>Animal-Free Manufacturing Conditions</h2> <p>Animal-free protein manufacturing minimizes performance variables and risk caused by trace animal components or mammalian pathogens. Each of our animal-free proteins is produced from an E. coli expression system, not mammalian cell lines. There is no animal component used anywhere in the manufacturing process. When possible, our GMP proteins are made in an entirely animal-free process. Learn more about our <a href="/reagents/proteins/animal-free-proteins">Animal-Free RUO Proteins</a>.</p></div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-read-our-full-animal-free-statement22" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Read our Full Animal-Free Statement</h5> </a> </div> <div class="collapse" id="expPara-read-our-full-animal-free-statement22" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>We maintain a completely animal-free environment; no animal-containing materials are permitted inside the facility or in contact with the laboratory equipment. The facilities are constructed to ensure there is no exposure of the product to contamination by animal-containing components, and there is clear segregation of all labware such as plasticware, tubing, gloves, pipette tips, and instruments. Our animal-free proteins share the same biological activities as those produced for our standard research grade, easing the process of transition between protein formats.</p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-animal-free-raw-materials-instrumentation-and-equipment12" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Animal-free Raw Materials, Instrumentation, and Equipment</h5> </a> </div> <div class="collapse" id="expPara-animal-free-raw-materials-instrumentation-and-equipment12" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><ul> <li>Animal-free Certificates of Origin from raw material suppliers.</li> <li>All raw materials are traceable through batch records</li> <li>Fermentation and purification processes follow approved SOPs</li> <li>Validated equipment cleaning procedures</li> <li>Dedicated animal-free fermenters</li> <li>Bacteria are grown in animal-free media</li> <li>Dedicated product-specific, animal-free columns</li> <li>Column cleaning validated for animal-free manufacturing</li> <li>Proteins filtered using certified animal-free filters</li> <li>Animal-free labware</li> <li>Animal-free containers and dedicated cold storage room</li> <li>Classified vialing clean room and dedicated animal-free lyophilizer</li> <li>Animal-free vials, stoppers, and crimp caps </li> </ul></div> </div> </div> </div> </div> <div> <div class="thin-banner banner_wrapper"> <div class="banner-dark"> <div> <div><h2>Interested in Testing an Animal-Free RUO Protein?</h2></div> <a href="/reagents/proteins/animal-free-proteins#sample-request" > <button type="button" class="btn btn-primary"> Request a Free Sample </button> </a> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--card-paragraph paragraph--view-mode--default card-para-default"> <div class="row card_row"> <div class="col-md-6"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <a href="https://resources.bio-techne.com/bio-techne-assets/images/literature/fl-key-considerations-for-cytokine-supplier-selection.pdf" > <div class="teaser-card-image-crop mb-3"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/key-consideration-for-cytokine-flyer-432x215-v2.jpg" alt="Key Considerations for Cytokine Supplier Selection Flyer 2" loading="lazy" > </div> </a> <a class="card_title_link" href="https://resources.bio-techne.com/bio-techne-assets/images/literature/fl-key-considerations-for-cytokine-supplier-selection.pdf" > <h3 class="card_title_htag"></h3> </a> <div class="card_description flex-grow-1"> <div><p>Integrate RUO-grade cytokines with equivalent GMP-grade options early in your discovery process. Take advantage of our cytokine performance consistency, supply chain, and GMP custom services.</p></div> </div> <div class="card-bottom-link"> <div> <a href="https://resources.bio-techne.com/bio-techne-assets/images/literature/fl-key-considerations-for-cytokine-supplier-selection.pdf" > Read Article </a> </div> </div> </div> </div> </div> <div class="col-md-6"> <div class="h-100"> <div class="bg-white border rounded flex-column d-flex h-100"> <a href="https://www.phacilitate.com/e-book/raw-materials-at-scale-success-factors-for-commercial-cell-and-gene-therapy-manufacturing/" > <div class="teaser-card-image-crop mb-3"> <img src="https://resources.bio-techne.com/bio-techne-assets/images/research-areas/phacilitate-teaser-box.jpg" alt="Phacilitate Exchange" loading="lazy" > </div> </a> <a class="card_title_link" href="https://www.phacilitate.com/e-book/raw-materials-at-scale-success-factors-for-commercial-cell-and-gene-therapy-manufacturing/" > <h3 class="card_title_htag"></h3> </a> <div class="card_description flex-grow-1"> <div><p>We have recently collaborated with <a href="https://www.phacilitate.com/" target="_blank">Phacilitate Exchange</a> to bring you this eBook that discusses best practices for scaling up raw materials in cell and gene therapy manufacturing.</p></div> </div> <div class="card-bottom-link"> <div> <a href="https://www.phacilitate.com/e-book/raw-materials-at-scale-success-factors-for-commercial-cell-and-gene-therapy-manufacturing/" > Read about Raw Materials at Scale </a> </div> </div> </div> </div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--freeform mb-4 paragraph--view-mode--default"> <div><h2><a name="GMP"></a>Bio-Techne's GMP Facilities</h2> <p>Find out more below about our GMP compliant facilities, dotted across the globe. Learn about the quality standards and certifications for each of our GMP facilities as well as our quality control testing capabilities. </p></div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-gmp-manufacturing-facility-in-saint-paul-mn15" role="button" aria-expanded="false" aria-controls="expPara"> <h5>GMP Manufacturing Facility in Saint Paul, MN</h5> </a> </div> <div class="collapse" id="expPara-gmp-manufacturing-facility-in-saint-paul-mn15" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>We have recently invested even more in the future of cell and gene therapy, because we are committed to supporting the increasing demand for GMP-grade ancillary proteins.</p> <p>Our new facility with approximately 61,000 square feet is dedicated to supporting large-scale production of GMP-grade materials including <em>E. coli</em>-derived recombinant proteins. Multiple fermenters and purification suites allow us to manufacture the large quantities of GMP proteins required in cell and gene therapy manufacturing processes.</p> <p><a href="/gmp-manufacturing-facility" target="_self">Learn More About Our New GMP Manufacturing Facility.</a></p></div> <a href="/gmp-products/gmp-facility-tour-request" class="btn btn-primary" type="link"> Request a Video Tour </a> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-bio-techne-headquarters-in-minneapolis-mn17" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Bio-Techne Headquarters in Minneapolis, MN</h5> </a> </div> <div class="collapse" id="expPara-bio-techne-headquarters-in-minneapolis-mn17" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-custom-services-minneapolis-hq.png" alt="Minneapolis" loading="lazy" > </div> <br/> <div><p>Our headquarters facility, home to R&D Systems, hosts a comprehensive team of expert scientists and proudly manufactures R&D Systems™ <a href="/gmp-proteins" target="_self">GMP recombinant proteins</a>, <a href="https://www.rndsystems.com/services/gmp-antibody-services" target="_blank">GMP antibodies</a>, <a href="https://www.rndsystems.com/services/custom-cell-culture-media-manufacturing-and-services" target="_blank">GMP cell culture products</a>, and <a href="https://www.rndsystems.com/services" target="_blank">custom GMP projects</a>.</p><p><strong>Certifications</strong></p><ul><li><a href="https://resources.rndsystems.com/pdfs/documents/rnd-systems-iso-13485-certificate.pdf" target="_blank">R&D Systems ISO 13485 Certificate</a></li><li><a href="https://resources.bio-techne.com/bio-techne-assets/docs/pdfs/FM-547845-ISO-9001.pdf" target="_blank">R&D Systems ISO 9001 Certificate</a></li><li><a href="https://resources.rndsystems.com/images/site/rnd-systems-iso-14001-ems-699287.pdf" target="_blank">R&D Systems ISO 14001 Certificate</a></li><li><a href="https://resources.bio-techne.com/bio-techne-assets/docs/pdfs/MDSAP-654945-12JUN2024.pdf" target="_blank">R&D Systems MDSAP Certificate</a></li><li>R&D Systems is a registered Medical Device Establishment under the U.S. Food, Drug, and Cosmetic Act, registration number 2182501, and is routinely inspected by the FDA.</li></ul><p><strong>Regulatory Guidelines Followed and Applicable Standards Followed </strong></p><ul><li>Quality System Regulations for Medical Devices</li><li>Code of Federal Regulations (21 CFR 820)</li><li>USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products</li><li>Applicable sections of the World Health Organization Good Manufacturing Practices for Biological Products: TRS, No 822, 1992 Annex 1</li><li>Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products</li><li>The In Vitro Diagnostic Directive 98/79/EC</li><li>The Canadian Medical Device Regulation</li></ul><p><strong>Standard Testing for GMP Proteins Includes</strong></p><ul><li>Mass spectrometry</li><li>HPLC</li><li>SDS-PAGE</li><li>N-terminal sequencing for first 10 amino acids</li><li>Mycoplasma</li><li>Endotoxin</li><li>Purity</li><li>Host cell protein and DNA</li><li>Bioburden/sterility in accordance with USP 71</li><li>Validated activity</li><li>Formal stability testing program over product shelf-life</li></ul><p><strong>Additional On-site Capabilities for Enhanced QC Testing</strong></p><ul><li>High resolution mass spectrometry: Intact mass, post-translational modifications, protein identification</li><li>Gel permeation chromatography/size exclusion chromatography (GPC/SEC): Aggregation assessment</li><li>Reverse phase HPLC: Purity assessment can reveal truncations, mixed disulfide patterns, and more</li><li>Light scattering analysis (SLS, DLS): Aggregation, oligomer analysis, and molecular weight determination when used in tandem with analytical sizing aggregation, oligomer analysis, and molecular weight determination</li><li>Advanced HPLC testing: Homogeneity</li><li>Surface plasmon resonance: Binding kinetics</li><li>Differential scanning fluorimetry (DSF): Protein stability and protein-ligand interactions</li><li>Cell bank and viral testing </li></ul><p> </p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-bristol-uk8" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Bristol, UK</h5> </a> </div> <div class="collapse" id="expPara-bristol-uk8" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-custom-services-bristol.png" alt="Bristol" loading="lazy" > </div> <br/> <div><p>Our Bristol facility manufactures GMP-grade small molecules and guarantees batch-to-batch consistency, consistency of supply, traceability from starting materials to final product, and animal-free production. We also provide <a href="https://www.rndsystems.com/products/gmp-quality-policy-and-regulatory-support" target="_blank">R&S Systems Quality and Regulatory Support</a>.</p> <p><strong>Regulatory Guidelines Followed</strong></p> <ul> <li>Relevant sections of ICH Q7 guidelines (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)</li> <li>USP Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products</li> </ul> <p><a href="https://resources.rndsystems.com/images/site/20210201-tocris-cookson-ltd-single-site-iso-9001-2015-a4.pdf" target="_blank">Tocris Bioscience – ISO Certification</a>.</p> <p><strong>QC Testing Available</strong></p> <ul> <li>Purity</li> <li>Product Identification</li> <li>Water Content</li> <li>Residue on Ignition</li> <li>Residual Solvents</li> <li>Solubility</li> <li>Bioburden</li> <li>Endotoxin</li> </ul> <p> </p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-newark-ca7" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Newark, CA</h5> </a> </div> <div class="collapse" id="expPara-newark-ca7" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-custom-services-newark.png" alt="Newark" loading="lazy" > </div> <br/> <div><p>In Newark, our <a href="/services/professional-assay-services-rnascope" target="_blank">Professional Assay Services</a> offer tissue sectioning, ISH staining, high resolution full slide scanning, scoring, and image analysis to support clinical and preclinical studies. Our dedicated team of highly trained specialists, scientists, and board-certified pathologists performs <a href="/reagents/rnascope-ish-technology" target="_self">RNAscope™ ISH</a>, <a href="/reagents/rnascope-ish-technology" target="_self">BaseScope™ ISH</a>, and <a href="/reagents/rnascope-ish-technology/manual-assays/mirnascope" target="_self">miRNAscope™ ISH assays</a> in singleplex, duplex, and multiplex formats. We operate under Good Clinical Laboratory Practice (GCLP) guidelines which encompass all aspects of individual laboratory operations including sample processing, generation of data, safety and security, employee training, documentation, and sample retention and recovery.</p> <p><strong>Certification</strong></p> <ul> <li>ISO 13485:2016</li> </ul> <p><strong>Regulatory Guidelines Followed </strong></p> <ul> <li>GCLP compliance according to 21 CFR 820</li> </ul> <p><strong>QC Testing for Our Raw Materials</strong></p> <ul> <li>Incoming inspection</li> <li>Visual inspection</li> <li>pH</li> <li>Conductivity</li> <li>Osmolality</li> <li>Enzymatic/end-point activity plate measurements</li> <li>ISH functional types of testing</li> </ul></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-san-marcos-ca0" role="button" aria-expanded="false" aria-controls="expPara"> <h5>San Marcos, CA</h5> </a> </div> <div class="collapse" id="expPara-san-marcos-ca0" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-custom-services-san-marcos.png" alt="San Marcos" loading="lazy" > </div> <br/> <div><p>Our Cliniqa facility provides dynamic, flexible, and regulatory compliant <a href="http://www.cliniqa.com/Custom-Manufacturing/Contract-Services.aspx" target="_blank">contract services</a> with in-house experts that support manufacturing organizations in the IVD market.</p> <p><strong>Certifications</strong></p> <ul> <li>ISO 13485:2016</li> <li>MDSAP; approval includes US, Canada, Brazil, Japan, Australia</li> </ul> <p><strong>Registrations and Licenses</strong></p> <ul> <li>Health Canada Establishment License: 2970</li> <li>USDA Technical Blood Facility, Intermediate Product Facility CA-TEC-0046 and CA-TEC-0053</li> <li>U.S. DEA Manufacturer and Exporter Registration</li> <li>California State Medical Device Manufacturing License: 50393</li> </ul> <p><strong>Service Capabilities</strong></p> <ul> <li>Assay development</li> <li>Technology transfer</li> <li>Packaging development</li> <li>Regulatory support</li> <li>Technical support</li> <li>Stability programs</li> </ul> <p><strong>Manufacturing Capabilities</strong></p> <ul> <li>Liquid formulation/filling</li> <li>Powder formulation</li> <li>Powder blending and filling</li> <li>Reagent tablets</li> <li>Lyophilization</li> <li>Off-line/in-line labeling</li> <li>Kit assembly/packaging</li> <li>Final product testing</li> </ul></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-devens-ma12" role="button" aria-expanded="false" aria-controls="expPara"> <h5>Devens, MA</h5> </a> </div> <div class="collapse" id="expPara-devens-ma12" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-custom-services-devens.png" alt="Devens" loading="lazy" > </div> <br/> <div><p>In <a href="http://bionostics.com/pages/index.php?page=home" target="_blank">Devens</a>, we provide technical and logistical resources for technology transfer and full product development across controls, buffers, calibrators, and standards for the IVD market.</p> <p><strong>Certifications</strong></p> <ul> <li>ISO 13485:2016</li> <li>ISO/CAN 13485:2003</li> <li>ISO 9001:2008</li> </ul> <p><strong>Regulatory Guidelines Followed</strong></p> <ul> <li>21 CFR Part 820</li> <li>78/79 EC for IVD</li> </ul> <p><strong>Analytical Testing Services</strong></p> <ul> <li>HPLC, chemistry, Immunoassays</li> <li>Spectrophotometry</li> <li>Conductivity, viscosity, pH, turbidity</li> <li>Microbiology</li> <li>Preservative efficacy</li> </ul> <p><strong>Analysis and Reporting</strong></p> <ul> <li>Protocol generation</li> <li>Method validation</li> <li>Documentation and reporting</li> </ul> <p><strong>Stability Testing Services</strong></p> <ul> <li>Real-time, transport, open container and accelerated</li> <li>Validated storage capable of -60 °C to +60 °C</li> <li>Environmental control settings of 10-80 %RH</li> <li>Consistent with European standard EN 13640:2002</li> </ul> <p><strong>Manufacturing</strong></p> <ul> <li>Formulation batch sizes from 15 mL to 1000 L</li> <li>Ampoule filling from 1 mL to 5 mL</li> <li>Pasteurization, autoclaving, irradiation</li> <li>Bottle and vial filling in a multitude of configurations</li> <li>Single use packaging in a variety of configurations</li> <li>Vision systems and weight checks</li> <li>Validation services</li> <li>Detailed documentation</li> <li>Custom design</li> </ul> <p> </p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-san-jose-ca13" role="button" aria-expanded="false" aria-controls="expPara"> <h5>San Jose, CA</h5> </a> </div> <div class="collapse" id="expPara-san-jose-ca13" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <div> <img src="https://resources.bio-techne.com/images/webinar/LP_images/cgt-custom-services-san-jose.png" alt="San Jose" loading="lazy" > </div> <br/> <div><p>We design, build, and validate ProteinSimple™ analytical instruments for use in clinical manufacturing environments. These instruments operate with 21 CFR Part 11-compliant software that ensures reliability, documentation, and data security.</p> <p><strong>Our Instruments Provide:</strong></p> <ul> <li>Secure access with comprehensive audit/log files</li> <li>User permission controls</li> <li>Automated batch protocols</li> <li>Method-based analysis protocols</li> <li>Automated date and time stamps</li> <li>Unique electronic signatures for each user</li> <li>Protected data repository</li> <li>Comprehensive reporting</li> <li>Electronic audit trail generation</li> </ul> <p><strong>Our 21 CFR Part 11-compliant Instrument Platforms Include: </strong></p> <ul> <li><a href="/instruments/simple-western">Simple Western™</a> systems for automated, capillary-based immunoassays that combine the power of CE-SDS or cIEF with the sensitivity of immunodetection, enabling size- and charge-based screening of complex sample types.</li> <li><a href="/instruments/ice" target="_self">iCE Maurice™</a> systems for capillary electrophoresis that automates protein profiling by size or charge, employing pre-assembled cartridges and featuring onboard sample mixing.</li> <li><a href="/instruments/micro-flow-imaging" target="_self">Micro-Flow Imaging™</a> for analysis of protein aggregation for stability measurements following stress testing. Up to 90 samples/ run, and up to 150 µL/minute at 900,000 particles/mL.</li> <li><a href="/instruments/simple-plex" target="_self">Simple Plex™</a> for automated ELISAs to detect fragments and oligomers of cytokines and growth factors with low assay CVs. Single or multianalyte cartridge format options available.</li> </ul> <p> </p></div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h2><a name="FAQ"></a>Frequently Asked Questions</h2></div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-1nbsphow-do-you-ensure-the-raw-materials-you-use-in-your-manufacturing-are-appropriate-to-make-products-that-can-be-used-fornbspex-vivonbspmanufacturing18" role="button" aria-expanded="false" aria-controls="expPara"> <h5>1. How do you ensure the raw materials you use in your manufacturing are appropriate to make products that can be used for ex vivo manufacturing?</h5> </a> </div> <div class="collapse" id="expPara-1nbsphow-do-you-ensure-the-raw-materials-you-use-in-your-manufacturing-are-appropriate-to-make-products-that-can-be-used-fornbspex-vivonbspmanufacturing18" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>Raw materials are sourced from qualified suppliers with supplier qualification and monitoring systems in place. We also perform risk assessments for critical raw materials used in GMP processes every three years. This includes visual inspection of raw materials with documentation tracking of the Certificate of Analysis (CoA), Certificate of Origin (CoO), TSE/BSE statements, and animal-free statements, if applicable. Identity confirmation is performed for some critical raw materials before accepting. For animal-derived materials, we always source from countries considered to be a negligible or controlled BSE risk.</p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-2nbspwhat-advice-would-you-give-to-cell-therapy-developers-when-sourcing-their-raw-materials23" role="button" aria-expanded="false" aria-controls="expPara"> <h5>2. What advice would you give to cell therapy developers when sourcing their raw materials?</h5> </a> </div> <div class="collapse" id="expPara-2nbspwhat-advice-would-you-give-to-cell-therapy-developers-when-sourcing-their-raw-materials23" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>We advise cell therapy developers to always source raw materials from USP-grade or GMP-grade if possible. Our GMP-grade products are manufactured and tested according to applicable standards in Unites States Pharmacopeia (USP) Section <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products, and European Pharmacopeia (Ph. Eur.) General Chapter 5.2.12 Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products. A supplier should have a certified quality management system (QMS), such as ISO 9001:2015 or ISO13485: 2016. This means the supplier has been independently audited and has policies and processes in place designed to meet the needs of their customers. Suppliers of these raw materials should be further qualified and monitored by questionnaire, performance of on time delivery, SCARs, and other auditing activities. The Certificate of Analysis, Certificate of Origin and other related documents should be received from each supplier and kept as development and manufacturing records.</p> <p>Developers should have early discussions about quality and supply agreements with suppliers to avoid surprises as you progress into production. A manufacturer should have the ability to scale up and meet your future needs in order to avoid late-stage changes that might require costly revalidation.</p> <p>Secondary suppliers should be identified early as well. Raw materials may look identical on a Certificate of Analysis but could behave differently in your biological system. It should never be assumed that you can easily switch between suppliers for a given raw material. Validation studies are required to show equivalency between raw materials from different suppliers. </p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-3nbsphow-do-you-ensure-a-smooth-transition-from-research-use-only-ruo-to-good-manufacturing-practice-gmpnbsp6" role="button" aria-expanded="false" aria-controls="expPara"> <h5>3. How do you ensure a smooth transition from research use only (RUO) to Good Manufacturing Practice (GMP)? </h5> </a> </div> <div class="collapse" id="expPara-3nbsphow-do-you-ensure-a-smooth-transition-from-research-use-only-ruo-to-good-manufacturing-practice-gmpnbsp6" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>If the same vendor is used, ideally, the physical characteristics of RUO-grade raw materials would be the same as GMP-grade. They would differ only in robust documentation, such as Quality Assurance personnel performing final review and approval of batch documentation, and formal validation conducted for GMP products. There should also be extensive safety testing of raw materials that might come into contact with patients. It is fair to ask a vendor whether the manufacturing processes are the same for RUO and GMP raw materials.</p> <p>If clinical applications are the goal, it is suggested that the switch to GMP be made early. Even during preclinical stages if possible. It is far easier to do equivalency testing early in product development than during later stages when changes can be costly and time-consuming.</p> <p>Choosing a vendor with experience can also be advantageous. This can mean having a good understanding of quality management systems, protein biochemistry, and analytical testing methods. In addition, experience in regulatory matters is key. An experienced vendor can help when navigating changing regulatory landscapes. Availability of Drug Master Files (DMF) that contain detailed information about the raw material can assist regulatory authorities and ease investigational new drug (IND) applications. If possible, audits of vendor facilities should be conducted, and virtual audits should be made available for those that can’t be done in person. The relationship between vendor and customer needs to be a partnership, and experience counts. A minimum of three consecutive lots are manufactured, tested, and released in accordance with approved standard operating procedures to meet pre-determined acceptance criteria. (The Quality Control department is responsible for final review and approval of RUO products). For products that were developed with RUO raw materials, there may have been modifications in the manufacturing process and/or final product testing which are applicable to the GMP product.  In this case, it is advisable that the GMP product is used for any <em>ex vivo</em> clinical studies.</p></div> </div> </div> </div> </div> <div> <div class="paragraph accordion mb-4 paragraph--type--extendable-paragraph paragraph--view-mode--default"> <div class="card-header rounded-top bg-white"> <a class="collapsed" data-toggle="collapse" href="#expPara-4nbspcell-and-gene-therapy-manufacturers-need-to-bridge-batches-lot-to-lot-consistency-gmp-testing-against-master-lot-how-can-you-ensure-lot-to-lot-consistency-and-reduce-variability5" role="button" aria-expanded="false" aria-controls="expPara"> <h5>4. Cell and gene therapy manufacturers need to bridge batches (lot-to-lot consistency, GMP testing against master lot). How can you ensure lot-to-lot consistency and reduce variability?</h5> </a> </div> <div class="collapse" id="expPara-4nbspcell-and-gene-therapy-manufacturers-need-to-bridge-batches-lot-to-lot-consistency-gmp-testing-against-master-lot-how-can-you-ensure-lot-to-lot-consistency-and-reduce-variability5" aria-expanded="false" aria-controls="expPara"> <div class="card-body p-4"> <br/> <div><p>Cytokines and growth factors are made in biological systems and can be susceptible to variability. They should only be released to market after successful manufacturing of many consecutive batches that have passed stringent specifications. This builds a solid foundation for future manufacturing consistency and reliability.</p> <p>Manufacturing processes must be controlled with rigorously documented SOPs and highly trained staff. This information should be made available during audit. It is fair to request data from several lots in order to assess a vendor’s ability to make proteins reproducibly. Ideally, materials from multiple lots should be obtained so they can be tested for consistency in your system. At Bio-Techne, we maintain master control lots. Each new bulk lot is compared against the master lot prior to release to market. This reduces variability and ensures consistent product performance.</p></div> </div> </div> </div> </div> <div> <div class="paragraph paragraph--type--header"> <div> <div><h2><a name="Form"></a>Inquire About Our GMP Capabilities</h2></div> </div> </div> </div> <div> <div id="block-bio-techne-global-content" class="paragraph"> <article> <div class="row"> <div class="col-8 offset-md-2 offset-sm-0"> <script src="//info.bio-techne.com/js/forms2/js/forms2.min.js"></script> <form id="mktoForm_6147"></form> <script>MktoForms2.loadForm("//info.bio-techne.com", "584-XSF-168", 6147);</script> </div> </div> </article> </div> </div> </div> </div> </article> </div> </div> </section> </main> </div> <div id="brandsbar-footer" class="bg-bt-primary"> <div class="container-wide container-fluid text-white"> <div class="row py-5"> <div class="footer-logo col-xl-3 col-lg-auto d-flex"> <img class="brand-bar-footer-logo" src="/themes/custom/bio_techne_global/logo.svg" alt="Bio-techne logo"> </div> <div 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