{"id":3103,"date":"2026-08-22T21:24:42","date_gmt":"2026-08-22T20:24:42","guid":{"rendered":"https:\/\/wheat-quail-856400.hostingersite.com\/?page_id=3103"},"modified":"2026-11-02T16:24:25","modified_gmt":"2026-11-02T15:24:25","slug":"what-is-atmp","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/what-is-atmp\/","title":{"rendered":"Was ist ein ATMP? Arzneimittel f\u00fcr neuartige Therapien"},"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-default-div 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;\">Kurzdefinition<\/p><p class=\"sb-hs-buy\" style=\"background:#f1faf9;border-left:4px solid #18b7b2;border-radius:8px;padding:12px 16px;margin:16px 0\">Sie m\u00f6chten kaufen? Alle Qualit\u00e4ten finden Sie unter <a href=\"https:\/\/seamlessbio.de\/de\/humanserum\/\">Humanserum<\/a> : gemischte Spender, Typ AB, Off-the-Clot, m\u00e4nnlich \u2013 EU-Lager, Chargenreservierung bis 36 Monate.<\/p>\n<p style=\"font-size:16px;margin:0;\"><strong>Was ist ein ATMP (Arzneimittel f\u00fcr neuartige Therapien)?<\/strong> Ein Arzneimittel f\u00fcr neuartige Therapien (ATMP, Advanced Therapy Medicinal Product) ist ein biologisches Arzneimittel auf Basis von Genen, Zellen oder Tissue Engineering \u2013 geregelt durch die EU-Verordnung (EG) Nr. 1394\/2007. Zu den ATMP geh\u00f6ren Gentherapeutika (GTMP), somatische Zelltherapeutika (sCTMP) und biotechnologisch bearbeitete Gewebeprodukte (TEP).<\/p>\n<\/div>\n<h2>Anforderungen an die ATMP-Herstellung<\/h2>\n<p>Die ATMP-Herstellung unter GMP erfordert: vollst\u00e4ndige R\u00fcckverfolgbarkeit aller Ausgangs- und Rohstoffe; Pr\u00fcfung auf Fremdagenzien (Mykoplasmen, Sterilit\u00e4t, Virussicherheit); validierte Prozesse mit definierten kritischen Qualit\u00e4tsattributen (CQA); und die Freigabe durch eine sachkundige Person (QP). Rohstoffe wie FKS, Humanserum und Albumin erfordern vollst\u00e4ndige Dokumentation \u2013 Speziesnachweis, TSE\/BSE-Erkl\u00e4rungen, Spenderscreening, Viruspr\u00fcfung. Die EMA empfiehlt nachdr\u00fccklich, Rohstoffe tierischen Ursprungs durch humane (xenofreie) oder rekombinante (ACF) Alternativen zu ersetzen.<\/p>\n<h2>Produkte von SeamlessBio f\u00fcr die ATMP-Herstellung<\/h2>\n<p>hPL (xenofrei f\u00fcr MSC-, T-Zell- und NK-Expansion), rHSA (ACF-Albumin), OsrhTF (ACF-Transferrin), FKS Low Endotoxin (wenn FKS erforderlich ist), humanes AB-Serum HI (PBMC- und Immunzellarbeiten). Alle mit vollst\u00e4ndigen regulatorischen Dokumentationspaketen.<\/p>\n<h2>Wichtige Fakten<\/h2>\n<ul>\n<li>Drei ATMP-Kategorien: Gentherapeutika (GTMP), somatische Zelltherapeutika (sCTMP), biotechnologisch bearbeitete Gewebeprodukte (TEP)<\/li>\n<li>Beispiele f\u00fcr GTMP: AAV-basierter Genersatz (Luxturna, Zolgensma), lentivirale Genkorrektur, In-vivo-CRISPR-Therapie<\/li>\n<li>Beispiele f\u00fcr sCTMP: CAR-T-Zellen (Kymriah, Yescarta), NK-Zelltherapien, MSC-basierte Immunmodulation<\/li>\n<li>Beispiele f\u00fcr TEP: k\u00fcnstlich hergestellter Knorpel, Haut\u00e4quivalente, Hornhautrekonstruktionen<\/li>\n<li>Der Ausschuss f\u00fcr neuartige Therapien (CAT) der EMA gibt wissenschaftliche Empfehlungen zur Einstufung und Zulassung von ATMP<\/li>\n<li>Herstellung: GMP-Anhang 2 und Anhang 16 gelten; xenofreie und idealerweise ACF-Rohstoffe werden klar bevorzugt<\/li>\n<li>Krankenhausausnahme (Hospital Exemption): EU-Mitgliedstaaten k\u00f6nnen nicht routinem\u00e4\u00dfig hergestellte ATMP ohne vollst\u00e4ndige Zulassung im Rahmen der Krankenhausausnahme erlauben<\/li>\n<\/ul>\n<h2>Weiterlesen<\/h2>\n<ul>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-xeno-free-cell-culture\/\">Was ist eine xeno-freie Zellkultur?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-animal-component-free-acf\/\">Was ist tierkomponentenfrei?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-human-platelet-lysate-hpl\/\">Was ist hPL?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/ipsc-stem-cell-culture\/\">Leitfaden iPSC- &amp; Stammzellkultur<\/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-Rohstoffe \u2013 hPL, rHSA, FKS Low Endotoxin | SeamlessBio<\/p>\n<a href=\"https:\/\/seamlessbio.de\/de\/produkte\/humanserum\/\" style=\"background:#18b7b2;color:#fff;padding:12px 28px;border-radius:50px;font-size:13px;font-weight:700;text-decoration:none;\">Zum Produkt \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 \u00b7 Passau, Deutschland \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 Looking to buy? See our human serum overview \u2013 all grades (mixed donors, Type AB, off-the-clot, male-only), EU stock, lot reservation up to 36 months. 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":{"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"class_list":["post-3103","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - 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? 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