{"id":3103,"date":"2026-08-22T21:24:42","date_gmt":"2026-08-22T20:24:42","guid":{"rendered":"https:\/\/seamlessbio.de\/?page_id=3103"},"modified":"2026-08-22T23:50:49","modified_gmt":"2026-08-22T22:50:49","slug":"what-is-atmp","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/what-is-atmp\/","title":{"rendered":"What is ATMP (Advanced Therapy Medicinal Product)?"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"3103\" class=\"elementor elementor-3103\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-18f37fc e-con e-atomic-element e-flexbox-base e-b4cb46d\" data-id=\"18f37fc\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"18f37fc\">\n    \t\t<div class=\"elementor-element elementor-element-de3cc31 elementor-widget elementor-widget-html\" data-id=\"de3cc31\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<!-- \nWORDPRESS PAGE \u2014 GUTENBERG \"BENUTZERDEFINIERTES HTML\" BLOCK\nSlug: what-is-atmp\nSEO Title: What is ATMP (Advanced Therapy Medicinal Product)? | SeamlessBio\nMeta Description: What is an ATMP, what categories does it cover, and what are the key regulatory and manufacturing requirements in the EU? Definition from SeamlessBio.\nFocus Keyword: what is ATMP advanced therapy medicinal product\nAdditional Keywords: ATMP definition EU regulation, gene therapy cell therapy ATMP, ATMP manufacturing GMP requirements\nMenu: Resources \u2192 Glossary\n-->\n<div style=\"background:#e9fbfa;border-left:4px solid #18b7b2;border-radius:0 8px 8px 0;padding:20px 24px;margin-bottom:32px;\">\n<p style=\"font-size:11px;font-weight:700;text-transform:uppercase;letter-spacing:1px;color:#139b97;margin-bottom:8px;\">Quick Definition<\/p>\n<p style=\"font-size:16px;margin:0;\"><strong>What is an ATMP (Advanced Therapy Medicinal Product)?:<\/strong> An Advanced Therapy Medicinal Product (ATMP) is a biological medicinal product based on genes, cells, or tissue engineering \u2014 regulated under EU Regulation (EC) No 1394\/2007. ATMPs include gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs), and tissue-engineered products (TEPs).<\/p>\n<\/div>\n<h2>ATMP manufacturing requirements<\/h2>\n<p>ATMP manufacturing under GMP requires: full traceability of all starting and raw materials; adventitious agent testing (mycoplasma, sterility, viral safety); validated processes with defined critical quality attributes (CQAs); and qualified person (QP) release. Raw materials including FBS, human serum, and albumin require full documentation \u2014 species certification, TSE\/BSE statements, donor screening, viral testing. EMA strongly encourages replacement of animal-derived raw materials with human-derived (xeno-free) or recombinant (ACF) alternatives.<\/p>\n<h2>SeamlessBio products for ATMP manufacturing<\/h2>\n<p>hPL (xeno-free for MSC, T cell, NK expansion), rHSA (ACF albumin), OsrhTF (ACF transferrin), FBS Low Endotoxin (when FBS required), human AB serum HI (PBMC and immune cell work). All supplied with full regulatory documentation packages.<\/p>\n<h2>Key Facts<\/h2>\n<ul>\n<li>Three ATMP categories: Gene Therapy Medicinal Products (GTMP), Somatic Cell Therapy Medicinal Products (sCTMP), Tissue-Engineered Products (TEP)<\/li>\n<li>GTMP examples: AAV-based gene replacement (Luxturna, Zolgensma), lentiviral gene correction, in vivo CRISPR therapy<\/li>\n<li>sCTMP examples: CAR-T cells (Kymriah, Yescarta), NK cell therapies, MSC-based immunomodulation<\/li>\n<li>TEP examples: engineered cartilage, skin equivalents, corneal reconstructions<\/li>\n<li>EMA Committee for Advanced Therapies (CAT) provides scientific recommendations for ATMP classification and approval<\/li>\n<li>Manufacturing: GMP Annex 2 and Annex 16 apply; xeno-free and ideally ACF raw materials strongly preferred<\/li>\n<li>Hospital Exemption (HE): EU member states may allow non-routine ATMPs under hospital exemption without full marketing authorisation<\/li>\n<\/ul>\n<h2>Further Reading<\/h2>\n<ul>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-xeno-free-cell-culture\/\">What is Xeno-Free Cell Culture?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-animal-component-free-acf\/\">What is Animal Component-Free?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-human-platelet-lysate-hpl\/\">What is hPL?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/ipsc-stem-cell-culture\/\">iPSC & Stem Cell Culture Guide<\/a><\/li>\n<\/ul>\n<div style=\"background:#f4f6f7;border-radius:12px;padding:32px;text-align:center;margin-top:40px;\">\n<p style=\"font-size:18px;font-weight:700;color:#1a2e35;margin-bottom:12px;\">ATMP Raw Materials \u2014 hPL, rHSA, FBS Low Endotoxin | SeamlessBio<\/p>\n<a href=\"https:\/\/seamlessbio.de\/de\/produkte\/menschliches-serum\/\" style=\"background:#18b7b2;color:#fff;padding:12px 28px;border-radius:50px;font-size:13px;font-weight:700;text-decoration:none;\">View Product \u2192<\/a>\n&nbsp;&nbsp;\n<a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" style=\"border:2px solid #18b7b2;color:#139b97;padding:10px 28px;border-radius:50px;font-size:13px;font-weight:700;text-decoration:none;\">Muster anfordern<\/a>\n<\/div>\n<p style=\"font-size:13px;color:#6b7f82;margin-top:32px;border-top:1px solid #d8e8e7;padding-top:16px;\">\n<em>SeamlessBio GmbH \u00b7 Passau, Germany \u00b7 <a href=\"mailto:info@seamlessbio.de\">info@seamlessbio.de<\/a><\/em>\n<\/p>\t\t\t\t<\/div>\n\t\t\n<\/div>\n\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Quick Definition What is an ATMP (Advanced Therapy Medicinal Product)?: An Advanced Therapy Medicinal Product (ATMP) is a biological medicinal product based on genes, cells, or tissue engineering \u2014 regulated [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_eb_attr":"","footnotes":""},"class_list":["post-3103","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What is ATMP (Advanced Therapy Medicinal Product)?<\/title>\n<meta name=\"description\" content=\"What is an ATMP, what categories does it cover, and what are the key regulatory and manufacturing requirements in the EU? Definition from SeamlessBio.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/seamlessbio.de\/de\/what-is-atmp\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What is ATMP (Advanced Therapy Medicinal Product)?\" \/>\n<meta property=\"og:description\" content=\"What is an ATMP, what categories does it cover, and what are the key regulatory and manufacturing requirements in the EU? Definition from SeamlessBio.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/seamlessbio.de\/de\/what-is-atmp\/\" \/>\n<meta property=\"og:site_name\" content=\"SeamlessBio\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-22T22:50:49+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/\",\"name\":\"What is ATMP (Advanced Therapy Medicinal Product)?\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\"},\"datePublished\":\"2026-08-22T20:24:42+00:00\",\"dateModified\":\"2026-08-22T22:50:49+00:00\",\"description\":\"What is an ATMP, what categories does it cover, and what are the key regulatory and manufacturing requirements in the EU? Definition from SeamlessBio.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/\"]}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/\",\"name\":\"SeamlessBio\",\"description\":\"Expert for biological materials for pharma, vaccines and research organizations\",\"publisher\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/seamlessbio.de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":[\"Organization\",\"Place\",\"ProfessionalService\"],\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#organization\",\"name\":\"SeamlessBio\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/\",\"logo\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/#local-main-organization-logo\"},\"image\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/#local-main-organization-logo\"},\"address\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/#local-main-place-address\"},\"telephone\":[\"+49 (851) 37932226\"],\"contactPoint\":{\"@type\":\"ContactPoint\",\"telephone\":\"+49 (851) 37932226\",\"email\":\"info@seamlessbio.de\"},\"openingHoursSpecification\":[{\"@type\":\"OpeningHoursSpecification\",\"dayOfWeek\":[\"Monday\",\"Tuesday\",\"Wednesday\",\"Thursday\",\"Friday\"],\"opens\":\"09:00\",\"closes\":\"17:00\"},{\"@type\":\"OpeningHoursSpecification\",\"dayOfWeek\":[\"Saturday\",\"Sunday\"],\"opens\":\"00:00\",\"closes\":\"00:00\"}],\"email\":\"info@seamlessbio.de\"},{\"@type\":\"PostalAddress\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/#local-main-place-address\",\"streetAddress\":\"Dr.-Ernst-Derra-Str. 4\",\"addressLocality\":\"Passau\",\"postalCode\":\"94036\",\"addressRegion\":\"Bavaria\",\"addressCountry\":\"DE\"},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-atmp\\\/#local-main-organization-logo\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/134428046-2.png\",\"contentUrl\":\"https:\\\/\\\/seamlessbio.de\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/134428046-2.png\",\"width\":973,\"height\":288,\"caption\":\"SeamlessBio\"}]}<\/script>\n<meta name=\"geo.placename\" content=\"Passau\" \/>\n<meta name=\"geo.region\" content=\"Deutschland\" \/>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"What is ATMP (Advanced Therapy Medicinal Product)?","description":"What is an ATMP, what categories does it cover, and what are the key regulatory and manufacturing requirements in the EU? Definition from SeamlessBio.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/seamlessbio.de\/de\/what-is-atmp\/","og_locale":"de_DE","og_type":"article","og_title":"What is ATMP (Advanced Therapy Medicinal Product)?","og_description":"What is an ATMP, what categories does it cover, and what are the key regulatory and manufacturing requirements in the EU? Definition from SeamlessBio.","og_url":"https:\/\/seamlessbio.de\/de\/what-is-atmp\/","og_site_name":"SeamlessBio","article_modified_time":"2026-08-22T22:50:49+00:00","twitter_card":"summary_large_image","twitter_misc":{"Gesch\u00e4tzte Lesezeit":"2\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/seamlessbio.de\/what-is-atmp\/","url":"https:\/\/seamlessbio.de\/what-is-atmp\/","name":"What is ATMP (Advanced Therapy Medicinal Product)?","isPartOf":{"@id":"https:\/\/seamlessbio.de\/#website"},"datePublished":"2026-08-22T20:24:42+00:00","dateModified":"2026-08-22T22:50:49+00:00","description":"What is an ATMP, what categories does it cover, and what are the key regulatory and manufacturing requirements in the EU? Definition from SeamlessBio.","breadcrumb":{"@id":"https:\/\/seamlessbio.de\/what-is-atmp\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/seamlessbio.de\/what-is-atmp\/"]}]},{"@type":"WebSite","@id":"https:\/\/seamlessbio.de\/#website","url":"https:\/\/seamlessbio.de\/","name":"SeamlessBio","description":"Experte f\u00fcr biologische Materialien f\u00fcr die Pharmaindustrie, Impfstoffe und Forschungseinrichtungen","publisher":{"@id":"https:\/\/seamlessbio.de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/seamlessbio.de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":["Organization","Place","ProfessionalService"],"@id":"https:\/\/seamlessbio.de\/#organization","name":"SeamlessBio","url":"https:\/\/seamlessbio.de\/","logo":{"@id":"https:\/\/seamlessbio.de\/what-is-atmp\/#local-main-organization-logo"},"image":{"@id":"https:\/\/seamlessbio.de\/what-is-atmp\/#local-main-organization-logo"},"address":{"@id":"https:\/\/seamlessbio.de\/what-is-atmp\/#local-main-place-address"},"telephone":["+49 (851) 37932226"],"contactPoint":{"@type":"ContactPoint","telephone":"+49 (851) 37932226","email":"info@seamlessbio.de"},"openingHoursSpecification":[{"@type":"OpeningHoursSpecification","dayOfWeek":["Monday","Tuesday","Wednesday","Thursday","Friday"],"opens":"09:00","closes":"17:00"},{"@type":"OpeningHoursSpecification","dayOfWeek":["Saturday","Sunday"],"opens":"00:00","closes":"00:00"}],"email":"info@seamlessbio.de"},{"@type":"PostalAddress","@id":"https:\/\/seamlessbio.de\/what-is-atmp\/#local-main-place-address","streetAddress":"Dr.-Ernst-Derra-Str. 4","addressLocality":"Passau","postalCode":"94036","addressRegion":"Bavaria","addressCountry":"DE"},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/seamlessbio.de\/what-is-atmp\/#local-main-organization-logo","url":"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046-2.png","contentUrl":"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046-2.png","width":973,"height":288,"caption":"SeamlessBio"}]},"geo.placename":"Passau","geo.region":"Deutschland"},"_links":{"self":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages\/3103","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/comments?post=3103"}],"version-history":[{"count":5,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages\/3103\/revisions"}],"predecessor-version":[{"id":3193,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/pages\/3103\/revisions\/3193"}],"wp:attachment":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/media?parent=3103"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}