Process Assessment & Development

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href="https://biologics.catalent.com/cell-therapy/cell-types/" title="" >Cell Type Solutions</a> </div> </li> </ul> </div> </li> <li> <div class="btn-group dropdown"> <a class="btn btn-menu" href="https://biologics.catalent.com/specialty/" title="" >Specialty</a> <button type="button" data-bs-offset="-70,0" class="btn dropdown-toggle" data-bs-toggle="dropdown" aria-expanded="false" aria-label="Show items in Specialty"> <span class="ch-icon-chevron-down" aria-hidden="true"></span> </button> <ul class="dropdown-menu"> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/biologics/drug-substance/bioconjugate-development/" title="" >Bioconjugates</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/specialty/bispecifics/" title="" >Bispecifics</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/specialty/plasmid-dna/" title="" >Plasmid DNA</a> 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href="https://biologics.catalent.com/biologics/drug-substance/bioconjugate-development/" title="" >Antibody Drug Conjugates (SMARTag®)</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/cell-therapy/ipscs/" title="" >iPSCs</a> </div> </li> </ul> </div> </li> <li> <div class="btn-group dropdown"> <a class="btn btn-menu" href="https://biologics.catalent.com/expert-content/" title="" >Expert Content</a> <button type="button" data-bs-offset="-70,0" class="btn dropdown-toggle" data-bs-toggle="dropdown" aria-expanded="false" aria-label="Show items in Expert Content"> <span class="ch-icon-chevron-down" aria-hidden="true"></span> </button> <ul class="dropdown-menu"> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/expert-content/?topic%5B%5D=3327" title="" >Biologics Analytical Services</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/expert-content/?topic%5B%5D=3328" title="" >Biologics Development</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/expert-content/?topic%5B%5D=6915" title="" >Cell Therapy</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/expert-content/?topic%5B%5D=3329" title="" >Drug Product Manufacturing</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/expert-content/?topic%5B%5D=3330" title="" >Drug Substance Manufacturing</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/expert-content/?topic%5B%5D=5424" title="" >Gene Therapy</a> </div> </li> <li> <div class="btn-group"> <a class="dropdown-item" href="https://biologics.catalent.com/expert-content/?topic%5B%5D=7771" title="" >Plasmid DNA</a> </div> </li> <li> <div 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class="level2"> <div class="btn-group"> <a class="btn btn-menu no-child" href="https://biologics.catalent.com/cell-therapy/cgmp-manufacturing/" title="" >CGMP Manufacturing</a> </div> </li> <li class="level2"> <div class="btn-group"> <a class="btn btn-menu no-child" href="https://biologics.catalent.com/cell-therapy/analytical-services/" title="" >Analytical Services</a> </div> </li> <li class="level2"> <div class="btn-group"> <a class="btn btn-menu no-child" href="https://biologics.catalent.com/cell-therapy/cell-types/" title="" >Cell Type Solutions</a> </div> </li> </ul> </li> <li class="level1"> <div class="btn-group"> <a class="btn btn-menu " href="https://biologics.catalent.com/specialty/" title="" >Specialty</a> <button type="button" class="btn collapse-toggle collapsed" data-bs-toggle="collapse" data-bs-target="#main-menu-3" aria-expanded="false" aria-controls="main-menu-3" aria-label="Show items in Specialty"> <span class="ch-icon-chevron-up" aria-hidden="true"></span> </button> 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btn-menu no-child" href="https://biologics.catalent.com/specialty/oncolytic-viruses/" title="" >Oncolytic Viruses</a> </div> </li> <li class="level2"> <div class="btn-group"> <a class="btn btn-menu no-child" href="https://biologics.catalent.com/specialty/orphan-drugs/" title="" >Orphan Drugs</a> </div> </li> </ul> </li> <li class="level1"> <div class="btn-group"> <a class="btn btn-menu " href="https://biologics.catalent.com/technologies/" title="" >Technologies</a> <button type="button" class="btn collapse-toggle collapsed" data-bs-toggle="collapse" data-bs-target="#main-menu-4" aria-expanded="false" aria-controls="main-menu-4" aria-label="Show items in Technologies"> <span class="ch-icon-chevron-up" aria-hidden="true"></span> </button> </div> <ul class="collapse" id="main-menu-4"> <li class="level2"> <div class="btn-group"> <a class="btn btn-menu no-child" href="https://biologics.catalent.com/biologics/drug-substance/cell-line-development/" title="" >Cell Line Development (GPEX®)</a> 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class="entry-content"> <div class="et-l et-l--post"> <div class="et_builder_inner_content et_pb_gutters3"> <div class="et_pb_section et_pb_section_0 et_section_regular" > <div class="et_pb_row et_pb_row_0"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_0 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_code et_pb_code_0"> <div class="et_pb_code_inner"><a name="top"></a></div> </div><div class="et_pb_module et_pb_dcsbcm_divi_breadcrumbs_module et_pb_dcsbcm_divi_breadcrumbs_module_0"> <div class="et_pb_module_inner"> <ol class="dcsbcm_divi_breadcrumbs" vocab="http://schema.org/" typeof="BreadcrumbList"><li class="dcsbcm_divi_breadcrumb" property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" href="https://biologics.catalent.com/"><span property="name">Home</span></a><meta property="position" content="1"></li><span class="dcsbcm_separator"> » </span><li class="dcsbcm_divi_breadcrumb" property="itemListElement" 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class="et_pb_module_inner"> <div class="ctl-title"> <div class="title-image image-large"> <img decoding="async" src="https://biologics.catalent.com/wp-content/uploads/sites/2/2020/07/ProcessDiagnosis_59x59.png" aria-hidden="true" /> </div> <div class="title-content" style="color:#332a86 !important;"> <h1>Process Assessment & Development</h1> </div> </div> </div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_2 et_pb_css_mix_blend_mode_passthrough et-last-child et_pb_column_empty"> </div> </div> </div><div class="et_pb_section et_pb_section_2 et_section_specialty" > <div class="et_pb_row"> <div class="et_pb_column et_pb_column_1_4 et_pb_column_3 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_sidebar_0 products_sidebar et_pb_widget_area clearfix et_pb_widget_area_left et_pb_bg_layout_light"> <div id="nav_menu-20" class="et_pb_widget widget_nav_menu"><div class="menu-ct-process-industrialization-container"><ul id="menu-ct-process-industrialization" class="menu"><li id="menu-item-218088" class="menu-item menu-item-type-post_type menu-item-object-page current-page-ancestor current-page-parent menu-item-218088"><a href="https://biologics.catalent.com/cell-therapy/process-development/">OVERVIEW</a></li> <li id="menu-item-231065" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-231065"><a href="https://biologics.catalent.com/cell-therapy/process-development/autologous-cell-therapy/">AUTOLOGOUS CELL THERAPY</a></li> <li id="menu-item-234847" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-234847"><a href="https://biologics.catalent.com/cell-therapy/process-development/allogeneic-cell-therapy/">ALLOGENIC CELL THERAPY</a></li> <li id="menu-item-236573" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-236573"><a href="https://biologics.catalent.com/cell-therapy/process-development/car-t-platform-process/">CAR-T PLATFORM PROCESS</a></li> <li id="menu-item-218102" class="menu-item menu-item-type-post_type menu-item-object-page current-menu-item page_item page-item-218094 current_page_item menu-item-218102"><a href="https://biologics.catalent.com/cell-therapy/process-development/process-assessment-and-development/" aria-current="page">PROCESS ASSESSMENT & DEVELOPMENT</a></li> <li id="menu-item-218112" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-218112"><a href="https://biologics.catalent.com/cell-therapy/process-development/manufacturing-by-design-methodology/">MANUFACTURING BY DESIGN METHODOLOGY</a></li> </ul></div></div> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_4 et_pb_specialty_column et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_row_inner et_pb_row_inner_0"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_0 et-last-child"> <div class="et_pb_module et_pb_divider et_pb_divider_0 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div><div class="et_pb_module et_pb_text et_pb_text_0 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p>At Catalent, we execute with a long-term vision for your cell therapy product. Our 5-step in-house approach translates your discoveries into manufacturable treatments at scale. We develop a comprehensive industrialization plan early on, reducing erroneous processes and manual steps, while accounting for parameters such as materials, new processes, testing and costs. This lays the foundation for a successful technology transfer, development, and industrialization. As you evolve with us, our custom methodology allows for a faster transition of your therapeutic to commercial phase. </p> <p>We approach the process development plan with an integrated analytical strategy while considering key assessment factors for both phases.</p> <h4>Process development</h4> <ul> <li>Scale-up or scale-out</li> <li>Costs and risk reduction</li> <li>Implementation of industrial equipment to automate the process</li> <li>Closing the open-phase stages</li> </ul> <h4>Analytical development</h4> <ul> <li>Rationalization of sampling plan</li> <li>Development of analytical methods</li> <li>Process and product characterization (potency assay) validation</li> <li>Product comparability throughout development</li> </ul> <p>We also employ a fully integrated team between the development and manufacturing phase, for a seamless transition of your cell therapy product, therefore, saving costs, resources, and time to market. We combine our CGMP expertise, our scientific and manufacturing know-how to address specialized needs of your cell type and your project.</p></div> </div> </div> </div><div class="et_pb_row_inner et_pb_row_inner_1"> <div class="et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_1 et-last-child"> <div class="et_pb_module et_pb_divider et_pb_divider_1 et_pb_divider_position_ et_pb_space"><div class="et_pb_divider_internal"></div></div> </div> </div> </div><div class="et_pb_column et_pb_column_1_4 et_pb_column_5 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Events</h4> </div> </div><div class="et_pb_module et_pb_sidebar_1 gt_event_widget et_pb_widget_area clearfix et_pb_widget_area_left et_pb_bg_layout_light"> <div id="recent-posts-widget-with-thumbnails-4" class="et_pb_widget recent-posts-widget-with-thumbnails"> <div id="rpwwt-recent-posts-widget-with-thumbnails-4" class="rpwwt-widget"> <ul> <li><a href="https://biologics.catalent.com/events/advanced-therapies-week-2025/"><span class="rpwwt-post-title">Advanced Therapies Week 2025</span></a><div class="rpwwt-post-excerpt">Date: January 20-23, 2025<span class="rpwwt-post-excerpt-more"></span></div></li> </ul> </div> </div> </div><div class="et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><h4>Expert Content</h4></div> </div><div class="et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"><p><a href="https://biologics.catalent.com/expert-content/cell-therapy/allogeneic-t-cell-therapies-efficient-commercial-manufacturing-readiness-using-manufacturing-by-design-methodology/">Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing by Design” Methodology</a></p> <p><a href="https://biologics.catalent.com/expert-content/cell-therapy/overcoming-scalability-challenges-with-autologous-therapies/">Overcoming Scalability Challenges with Autologous Therapies</a></p></div> </div><div class="et_pb_button_module_wrapper et_pb_button_0_wrapper et_pb_button_alignment_center et_pb_module "> <a class="et_pb_button et_pb_button_0 et_pb_bg_layout_light" href="https://biologics.catalent.com/contact-us/" data-icon="5">Contact Us</a> </div> </div> </div> </div> </div> </div> </div> </article> </div> <footer id="catalent-footer" class="catalent-footer"> <div class="container"> <div class="row sec-main-menu"> <nav class="main-menu" aria-label="Footer menu"> <a href="https://biologics.catalent.com/expert-content/" title="Expert Content" >Expert Content</a> <a href="https://biologics.catalent.com/email-subscribe/" title="Subscribe" >Subscribe</a> <a href="https://investor.catalent.com/" title="Investors" >Investors</a> <a href="https://biologics.catalent.com/contact-us/" title="Contact Us" >Contact Us</a> <a href="https://biologics.catalent.com/site-map/" title="Site Map" >Site Map</a> </nav> <nav class="social-menu" aria-label="Social Media menu"> <div class="sec-title">Follow Us. 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