Zelltherapie und Gentherapie \u2013 Anwendungsleitf\u00e4den | SeamlessBio<\/title>\n\n<style>\n:root {\n --teal: #18b7b2; --teal-dark: #139b97; --teal-pale: #e9fbfa;\n --dark: #1a2e35; --grey: #f4f6f7; --border: #d8e8e7;\n --text: #2c3e3f; --muted: #6b7f82; --white: #ffffff;\n}\n*, *::before, *::after { box-sizing: border-box; margin: 0; padding: 0; }\nbody { font-family: 'Helvetica Neue', Arial, sans-serif; font-size: 16px; line-height: 1.7; color: var(--text); background: var(--white); max-width: 1100px; margin: 0 auto; padding: 0 20px; }\nh1 { font-size: 32px; font-weight: 800; color: var(--dark); line-height: 1.2; }\nh2 { font-size: 20px; font-weight: 700; color: var(--dark); margin: 48px 0 16px; padding-bottom: 8px; border-bottom: 2px solid var(--teal); }\nh3 { font-size: 16px; font-weight: 700; color: var(--dark); margin: 0 0 8px; }\np { margin-bottom: 14px; }\na { color: var(--teal-dark); text-decoration: none; }\na:hover { text-decoration: underline; }\nul { padding-left: 20px; 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}\n.cta-contact a { color: var(--teal-dark); }\n.cta-buttons { display: flex; justify-content: center; gap: 16px; flex-wrap: wrap; }\n.cta-btn-primary { background: var(--teal); color: var(--white); padding: 14px 32px; border-radius: 50px; font-size: 13px; font-weight: 700; letter-spacing: 0.5px; text-decoration: none; }\n.cta-btn-primary:hover { background: var(--teal-dark); text-decoration: none; }\n.cta-btn-outline { border: 2px solid var(--teal); color: var(--teal-dark); padding: 14px 32px; border-radius: 50px; font-size: 13px; font-weight: 700; text-decoration: none; }\n.cta-btn-outline:hover { background: var(--teal-pale); text-decoration: none; }\n@media (max-width: 640px) {\n .hero { grid-template-columns: 1fr; padding: 32px 24px; }\n .hero-right { flex-direction: row; }\n .hero-stat { flex: 1; }\n h1 { font-size: 22px; }\n .guides-grid { grid-template-columns: 1fr; }\n .products-strip { grid-template-columns: 1fr 1fr; }\n .cta-box { padding: 32px 20px; }\n}\n<\/style>\n<\/head>\n<body>\n\n<div class=\"hero\">\n <div class=\"hero-left\">\n <div class=\"eyebrow\">Anwendungskategorie \u00b7 Zell- und Gentherapie<\/div>\n <h1>Zelltherapie und Gentherapie \u2013 Anwendungsleitf\u00e4den<\/h1>\n <p class=\"lead\">Drei Fachleitf\u00e4den zu ATMP- und Gentherapie-Herstellungsabl\u00e4ufen \u2013 von der Kultivierung von iPS- und hPS-Zellen \u00fcber die Herstellung von AAV-Virusvektoren in HEK293T-Zellen bis hin zur Produktion monoklonaler Antik\u00f6rper mittels Hybridom-Technologie.<\/p>\n <\/div>\n <div class=\"hero-right\">\n <div class=\"hero-stat\"><div class=\"stat-num\">3<\/div><div class=\"stat-label\">Anwendungsleitf\u00e4den<\/div><\/div>\n <div class=\"hero-stat\"><div class=\"stat-num\">5<\/div><div class=\"stat-label\">Abgedeckte FBS-Pr\u00fcfungsstufen<\/div><\/div>\n <\/div>\n<\/div>\n\n<p style=\"font-size:16px; color:#2c3e3f; max-width:820px; margin-bottom:32px;\">Die Herstellung von Zell- und Gentherapien stellt h\u00f6chste Anforderungen an die Qualit\u00e4t biologischer Rohstoffe. Schon ein einziger Chargenwechsel bei FBS kann die Ausbeute an viralen Vektoren um das Zehnfache ver\u00e4ndern, die Differenzierungseffizienz von iPS-Zellen beeintr\u00e4chtigen oder dazu f\u00fchren, dass Rinder-IgG zusammen mit Ihrem therapeutischen mAb aufgereinigt wird. Diese Leitf\u00e4den behandeln die Auswahl des Serums, die Chargenpr\u00fcfung und die Entscheidungen zur biotechnologischen Verarbeitung, die \u00fcber den Erfolg der Herstellung entscheiden \u2013 vom Forschungsma\u00dfstab bis zur klinischen GMP-Produktion.<\/p>\n\n<div class=\"guides-grid\">\n<div class=\"guide-card\">\n <span class=\"guide-tag\">Gentherapie<\/span>\n <h3>Herstellung von AAV-Virusvektoren \u2013 Leitfaden f\u00fcr HEK293T und FBS<\/h3>\n <p>Wie das FBS-Endotoxin die AAV-Ausbeute verringert, das Protokoll f\u00fcr die Chargenpr\u00fcfung, wann auf serumfreie Medien umgestellt werden sollte und die Verwendung von Einwegmaterialien in der Bioproduktion f\u00fcr die Skalierung von rAAV.<\/p>\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/aav-viral-vector-production\/\" class=\"guide-link\">Anleitung lesen \u2192<\/a>\n<\/div>\n<div class=\"guide-card\">\n <span class=\"guide-tag\">Stammzellbiologie<\/span>\n <h3>iPS-Zellen und Stammzellkulturen \u2013 Leitfaden zu feederfreien Medien und Serum<\/h3>\n <p>Bei der iPS-Zellkultur wird das FBS-Medium verwendet, bei serumfreier Kultur HiDef-B8 als Alternative zu mTeSR und eine differenzierungsspezifische Serumstrategie je nach Zelllinie.<\/p>\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/ipsc-stem-cell-culture\/\" class=\"guide-link\">Anleitung lesen \u2192<\/a>\n<\/div>\n<div class=\"guide-card\">\n <span class=\"guide-tag\">Antik\u00f6rperproduktion<\/span>\n <h3>Hybridom- und mAb-Produktion \u2013 Leitfaden zu FBS und Serum<\/h3>\n <p>Dreistufige Serumstrategie f\u00fcr die Hybridomafusion, Klonierung und mAb-Produktion \u2013 \u201eLow IgG\u201c und \u201eUltra Low IgG FBS\u201c f\u00fcr die Protein-A\/G-Aufreinigung.<\/p>\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/hybridoma-monoclonal-antibody-production\/\" class=\"guide-link\">Anleitung lesen \u2192<\/a>\n<\/div>\n<\/div>\n\n<h2>Empfohlene Produkte f\u00fcr die Zell- und Gentherapie<\/h2>\n<div class=\"products-strip\">\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fbs-mit-geringem-endotoxingehalt\/\" class=\"prod-pill\">\u2192 FBS mit geringem Endotoxingehalt \u2014 AAV \/ HEK293T<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fbs-ultra-niedriges-igg\/\" class=\"prod-pill\">\u2192 FBS Ultra Low IgG \u2013 Produktion von monoklonalen Antik\u00f6rpern<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fbs-niedrig-igg\/\" class=\"prod-pill\">\u2192 FBS Niedriges IgG \u2014 Hybridomakultur<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/albuminproteine\/\" class=\"prod-pill\">\u2192 rHSA \u2014 Serumfreies Erg\u00e4nzungsmittel<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/single-use-bioprocessing\/\" class=\"prod-pill\">\u2192 Einwegbeutel f\u00fcr die Bioprozessierung<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" class=\"prod-pill\">\u2192 HiDef-B8 \u2013 iPSC-Pflege-Kit<\/a>\n<\/div>\n\n<h2>Wichtige regulatorische Aspekte<\/h2>\n<p>Zell- und Gentherapieprodukte unterliegen in der EU der Verordnung ATMP (Arzneimittel f\u00fcr neuartige Therapien) und in den USA den BLA-\/IND-Rahmenbedingungen. F\u00fcr das bei der Herstellung verwendete FBS ist eine l\u00fcckenlose R\u00fcckverfolgbarkeitsdokumentation erforderlich \u2013 einschlie\u00dflich Herkunftsland, TSE\/BSE-Erkl\u00e4rung, Endotoxin- und Sterilit\u00e4tspr\u00fcfungen sowie eines Virus-Sicherheitsprofils. SeamlessBio bietet vollst\u00e4ndige Pakete mit beh\u00f6rdlichen Unterlagen f\u00fcr GLP- und Pre-GMP-Antr\u00e4ge:<\/p>\n<ul>\n <li>Analysezertifikat (Sterilit\u00e4t, Mykoplasmen, Endotoxine, H\u00e4moglobin, Viruspanel)<\/li>\n <li>TSE\/BSE-Bescheinigung und Herkunftsbescheinigung<\/li>\n <li>USDA-Einfuhrgenehmigung (f\u00fcr Antr\u00e4ge gem\u00e4\u00df US-amerikanischen Vorschriften)<\/li>\n <li>Dokumentation zur Chargenreservierung f\u00fcr Br\u00fcckenstudien mit mehreren Chargen<\/li>\n <li>BVDV-RNA\/qPCR-Test (Zusatzleistung, separat abgerechnet)<\/li>\n<\/ul>\n\n<div class=\"back-link-wrap\">\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/\" class=\"back-link\">\u2190 \u00dcbersicht \u00fcber alle Anwendungsleitf\u00e4den<\/a>\n<\/div>\n\n<div class=\"cta-box\">\n <h2 class=\"cta-title\">FBS in Regulierungsqualit\u00e4t f\u00fcr die Herstellung von ATMP<\/h2>\n <p class=\"cta-text\">Fordern Sie ein Dokumentationspaket, ein Angebot zur Chargenreservierung oder ein FBS-Muster mit niedrigem Endotoxingehalt f\u00fcr Ihren AAV-, iPSC- oder mAb-Herstellungsworkflow an.<\/p>\n <p class=\"cta-contact\">E-Mail: info@seamlessbio.de | +49 851 37932226 | <a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\">seamlessbio.de\/kontakt<\/a><\/p>\n <div class=\"cta-buttons\">\n <a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" class=\"cta-btn-primary\">ANGEBOT UND UNTERLAGEN ANFORDERN<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fotales-rinderserum\/\" class=\"cta-btn-outline\">FBS-PORTFOLIO \u2192<\/a>\n <\/div>\n<\/div>\n\n<\/body>\n<\/html>\t\t\t\t<\/div>\n\t\t\n<\/div>\n\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Cell Therapy & Gene Therapy \u2014 Application Guides | SeamlessBio Application Category \u00b7 Cell & Gene Therapy Cell Therapy & Gene Therapy \u2014 Application Guides Three expert guides for ATMP […]<\/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-2709","page","type-page","status-publish","hentry"],"yoast_head":"\n<title>Cell Therapy & Gene Therapy \u2014 Application Guides | SeamlessBio<\/title>\n<meta name=\"description\" content=\"Application guides for cell & gene therapy manufacturing: iPSC culture, AAV viral vector production, hybridoma mAb production \u2014 FBS, single-use bags & reagents 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\/zelltherapie-gentherapie\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cell Therapy & Gene Therapy \u2014 Application Guides | 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}\n.cta-contact a { color: var(--teal-dark); }\n.cta-buttons { display: flex; justify-content: center; gap: 16px; flex-wrap: wrap; }\n.cta-btn-primary { background: var(--teal); color: var(--white); padding: 14px 32px; border-radius: 50px; font-size: 13px; font-weight: 700; letter-spacing: 0.5px; text-decoration: none; }\n.cta-btn-primary:hover { background: var(--teal-dark); text-decoration: none; }\n.cta-btn-outline { border: 2px solid var(--teal); color: var(--teal-dark); padding: 14px 32px; border-radius: 50px; font-size: 13px; font-weight: 700; text-decoration: none; }\n.cta-btn-outline:hover { background: var(--teal-pale); text-decoration: none; }\n@media (max-width: 640px) {\n .hero { grid-template-columns: 1fr; padding: 32px 24px; }\n .hero-right { flex-direction: row; }\n .hero-stat { flex: 1; }\n h1 { font-size: 22px; }\n .guides-grid { grid-template-columns: 1fr; }\n .products-strip { grid-template-columns: 1fr 1fr; }\n .cta-box { padding: 32px 20px; }\n}\n<\/style>\n<\/head>\n<body>\n\n<div class=\"hero\">\n <div class=\"hero-left\">\n <div class=\"eyebrow\">Anwendungskategorie \u00b7 Zell- und Gentherapie<\/div>\n <h1>Zelltherapie und Gentherapie \u2013 Anwendungsleitf\u00e4den<\/h1>\n <p class=\"lead\">Drei Fachleitf\u00e4den zu ATMP- und Gentherapie-Herstellungsabl\u00e4ufen \u2013 von der Kultivierung von iPS- und hPS-Zellen \u00fcber die Herstellung von AAV-Virusvektoren in HEK293T-Zellen bis hin zur Produktion monoklonaler Antik\u00f6rper mittels Hybridom-Technologie.<\/p>\n <\/div>\n <div class=\"hero-right\">\n <div class=\"hero-stat\"><div class=\"stat-num\">3<\/div><div class=\"stat-label\">Anwendungsleitf\u00e4den<\/div><\/div>\n <div class=\"hero-stat\"><div class=\"stat-num\">5<\/div><div class=\"stat-label\">Abgedeckte FBS-Pr\u00fcfungsstufen<\/div><\/div>\n <\/div>\n<\/div>\n\n<p style=\"font-size:16px; color:#2c3e3f; max-width:820px; margin-bottom:32px;\">Die Herstellung von Zell- und Gentherapien stellt h\u00f6chste Anforderungen an die Qualit\u00e4t biologischer Rohstoffe. Schon ein einziger Chargenwechsel bei FBS kann die Ausbeute an viralen Vektoren um das Zehnfache ver\u00e4ndern, die Differenzierungseffizienz von iPS-Zellen beeintr\u00e4chtigen oder dazu f\u00fchren, dass Rinder-IgG zusammen mit Ihrem therapeutischen mAb aufgereinigt wird. Diese Leitf\u00e4den behandeln die Auswahl des Serums, die Chargenpr\u00fcfung und die Entscheidungen zur biotechnologischen Verarbeitung, die \u00fcber den Erfolg der Herstellung entscheiden \u2013 vom Forschungsma\u00dfstab bis zur klinischen GMP-Produktion.<\/p>\n\n<div class=\"guides-grid\">\n<div class=\"guide-card\">\n <span class=\"guide-tag\">Gentherapie<\/span>\n <h3>Herstellung von AAV-Virusvektoren \u2013 Leitfaden f\u00fcr HEK293T und FBS<\/h3>\n <p>Wie das FBS-Endotoxin die AAV-Ausbeute verringert, das Protokoll f\u00fcr die Chargenpr\u00fcfung, wann auf serumfreie Medien umgestellt werden sollte und die Verwendung von Einwegmaterialien in der Bioproduktion f\u00fcr die Skalierung von rAAV.<\/p>\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/aav-viral-vector-production\/\" class=\"guide-link\">Anleitung lesen \u2192<\/a>\n<\/div>\n<div class=\"guide-card\">\n <span class=\"guide-tag\">Stammzellbiologie<\/span>\n <h3>iPS-Zellen und Stammzellkulturen \u2013 Leitfaden zu feederfreien Medien und Serum<\/h3>\n <p>Bei der iPS-Zellkultur wird das FBS-Medium verwendet, bei serumfreier Kultur HiDef-B8 als Alternative zu mTeSR und eine differenzierungsspezifische Serumstrategie je nach Zelllinie.<\/p>\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/ipsc-stem-cell-culture\/\" class=\"guide-link\">Anleitung lesen \u2192<\/a>\n<\/div>\n<div class=\"guide-card\">\n <span class=\"guide-tag\">Antik\u00f6rperproduktion<\/span>\n <h3>Hybridom- und mAb-Produktion \u2013 Leitfaden zu FBS und Serum<\/h3>\n <p>Dreistufige Serumstrategie f\u00fcr die Hybridomafusion, Klonierung und mAb-Produktion \u2013 \u201eLow IgG\u201c und \u201eUltra Low IgG FBS\u201c f\u00fcr die Protein-A\/G-Aufreinigung.<\/p>\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/hybridoma-monoclonal-antibody-production\/\" class=\"guide-link\">Anleitung lesen \u2192<\/a>\n<\/div>\n<\/div>\n\n<h2>Empfohlene Produkte f\u00fcr die Zell- und Gentherapie<\/h2>\n<div class=\"products-strip\">\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fbs-mit-geringem-endotoxingehalt\/\" class=\"prod-pill\">\u2192 FBS mit geringem Endotoxingehalt \u2014 AAV \/ HEK293T<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fbs-ultra-niedriges-igg\/\" class=\"prod-pill\">\u2192 FBS Ultra Low IgG \u2013 Produktion von monoklonalen Antik\u00f6rpern<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fbs-niedrig-igg\/\" class=\"prod-pill\">\u2192 FBS Niedriges IgG \u2014 Hybridomakultur<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/albuminproteine\/\" class=\"prod-pill\">\u2192 rHSA \u2014 Serumfreies Erg\u00e4nzungsmittel<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/single-use-bioprocessing\/\" class=\"prod-pill\">\u2192 Einwegbeutel f\u00fcr die Bioprozessierung<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" class=\"prod-pill\">\u2192 HiDef-B8 \u2013 iPSC-Pflege-Kit<\/a>\n<\/div>\n\n<h2>Wichtige regulatorische Aspekte<\/h2>\n<p>Zell- und Gentherapieprodukte unterliegen in der EU der Verordnung ATMP (Arzneimittel f\u00fcr neuartige Therapien) und in den USA den BLA-\/IND-Rahmenbedingungen. F\u00fcr das bei der Herstellung verwendete FBS ist eine l\u00fcckenlose R\u00fcckverfolgbarkeitsdokumentation erforderlich \u2013 einschlie\u00dflich Herkunftsland, TSE\/BSE-Erkl\u00e4rung, Endotoxin- und Sterilit\u00e4tspr\u00fcfungen sowie eines Virus-Sicherheitsprofils. SeamlessBio bietet vollst\u00e4ndige Pakete mit beh\u00f6rdlichen Unterlagen f\u00fcr GLP- und Pre-GMP-Antr\u00e4ge:<\/p>\n<ul>\n <li>Analysezertifikat (Sterilit\u00e4t, Mykoplasmen, Endotoxine, H\u00e4moglobin, Viruspanel)<\/li>\n <li>TSE\/BSE-Bescheinigung und Herkunftsbescheinigung<\/li>\n <li>USDA-Einfuhrgenehmigung (f\u00fcr Antr\u00e4ge gem\u00e4\u00df US-amerikanischen Vorschriften)<\/li>\n <li>Dokumentation zur Chargenreservierung f\u00fcr Br\u00fcckenstudien mit mehreren Chargen<\/li>\n <li>BVDV-RNA\/qPCR-Test (Zusatzleistung, separat abgerechnet)<\/li>\n<\/ul>\n\n<div class=\"back-link-wrap\">\n <a href=\"https:\/\/seamlessbio.de\/de\/anwendungen\/\" class=\"back-link\">\u2190 \u00dcbersicht \u00fcber alle Anwendungsleitf\u00e4den<\/a>\n<\/div>\n\n<div class=\"cta-box\">\n <h2 class=\"cta-title\">FBS in Regulierungsqualit\u00e4t f\u00fcr die Herstellung von ATMP<\/h2>\n <p class=\"cta-text\">Fordern Sie ein Dokumentationspaket, ein Angebot zur Chargenreservierung oder ein FBS-Muster mit niedrigem Endotoxingehalt f\u00fcr Ihren AAV-, iPSC- oder mAb-Herstellungsworkflow an.<\/p>\n <p class=\"cta-contact\">E-Mail: info@seamlessbio.de | +49 851 37932226 | <a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\">seamlessbio.de\/kontakt<\/a><\/p>\n <div class=\"cta-buttons\">\n <a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" class=\"cta-btn-primary\">ANGEBOT UND UNTERLAGEN ANFORDERN<\/a>\n <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/fotales-rinderserum\/\" class=\"cta-btn-outline\">FBS-PORTFOLIO \u2192<\/a>\n <\/div>\n<\/div>\n\n<\/body>\n<\/html>\t\t\t\t<\/div>\n\t\t\n<\/div>\n\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Cell Therapy & Gene Therapy \u2014 Application Guides | SeamlessBio Application Category \u00b7 Cell & Gene Therapy Cell Therapy & Gene Therapy \u2014 Application Guides Three expert guides for ATMP […]<\/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-2709","page","type-page","status-publish","hentry"],"yoast_head":"\n<title>Cell Therapy & Gene Therapy \u2014 Application Guides | SeamlessBio<\/title>\n<meta name=\"description\" content=\"Application guides for cell & gene therapy manufacturing: iPSC culture, AAV viral vector production, hybridoma mAb production \u2014 FBS, single-use bags & reagents 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\/zelltherapie-gentherapie\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cell Therapy & Gene Therapy \u2014 Application Guides | 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