{"id":9013,"date":"2026-09-24T23:00:00","date_gmt":"2026-09-24T23:00:00","guid":{"rendered":"https:\/\/seamlessbio.de\/?p=9013"},"modified":"2026-09-24T14:43:36","modified_gmt":"2026-09-24T13:43:36","slug":"what-is-atmp-advanced-therapy-medicinal-product","status":"publish","type":"post","link":"https:\/\/seamlessbio.de\/de\/what-is-atmp-advanced-therapy-medicinal-product\/","title":{"rendered":"What is an ATMP (Advanced Therapy Medicinal Product)?"},"content":{"rendered":"<p>Advanced Therapy Medicinal Products (ATMPs) are a class of biological medicines defined under EU Regulation 1394\/2007, encompassing gene therapy products, somatic cell therapy products, and tissue-engineered products. ATMPs represent some of the most complex and innovative treatments in modern medicine, including CAR-T cell therapies, stem cell transplants, and gene-corrected cell products.<\/p>\n<h2>Categories of ATMPs<\/h2>\n<p><strong>Gene Therapy Products<\/strong> contain recombinant nucleic acid sequences intended to regulate, repair, or replace a gene sequence. <strong>Cell Therapy Products<\/strong> contain cells that have been manipulated or are intended to perform a pharmacological, immunological, or metabolic action. <strong>Tissue-Engineered Products<\/strong> contain cells or tissues that have been engineered to regenerate, repair, or replace human tissue.<\/p>\n<h2>Regulatory Requirements for ATMPs in the EU<\/h2>\n<p>ATMPs are regulated by the EMA&#8217;s Committee for Advanced Therapies (CAT) and require centralized marketing authorization. Manufacturing must comply with EU GMP Annex 2A for ATMPs, with specific requirements for raw material qualification, traceability, and contamination control.<\/p>\n<h2>Serum and Media Considerations for ATMP Manufacturing<\/h2>\n<p>For GMP ATMP manufacturing, animal-derived components such as FBS must be qualified and ideally replaced with human-derived or recombinant alternatives (e.g., HPL, recombinant albumin) to reduce xenogeneic risk and regulatory burden.<\/p>\n<p><a href=\"\/de\/auto-t-zelltherapie\/\"><strong>\u2192 Cell Therapy &amp; ATMP Media Solutions<\/strong><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>ATMPs are gene therapies, cell therapies, and tissue-engineered products. Learn what ATMPs are, how they&#8217;re regulated in the EU, and what serum and media requirements apply.<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_eb_attr":"","_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"categories":[46],"tags":[],"class_list":["post-9013","post","type-post","status-publish","format-standard","hentry","category-cell-culture"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What is an ATMP? \u2014 Advanced Therapy Medicinal Products Explained<\/title>\n<meta name=\"description\" content=\"ATMPs are gene therapies, cell therapies, and tissue-engineered products. 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