{"id":9121,"date":"2026-09-30T17:54:52","date_gmt":"2026-09-30T16:54:52","guid":{"rendered":"https:\/\/wheat-quail-856400.hostingersite.com\/?p=9121"},"modified":"2026-10-20T10:41:44","modified_gmt":"2026-10-20T09:41:44","slug":"human-serum-atmp-manufacturing-gmp","status":"publish","type":"post","link":"https:\/\/seamlessbio.de\/de\/human-serum-atmp-manufacturing-gmp\/","title":{"rendered":"Humanserum f\u00fcr ATMP"},"content":{"rendered":"<!-- ============================================================\n   SeamlessBio Blog Post \u2014 sb-bp Format\n   Slug:        human-serum-atmp-manufacturing-gmp\n   SEO Title:   Human Serum for ATMP Manufacturing: GMP Requirements  (55 chars \u2713)\n   Meta Desc:   GMP-grade human serum for ATMP and cell therapy manufacturing \u2014 donor screening, viral safety, lot qualification, and EU regulatory requirements. (150 chars \u2713)\n   Keyphrase:   human serum ATMP manufacturing GMP\n   Int. links:  \/human-sera-plasma-and-more\/ \u00b7 \/human-plasma-apheresis-plasma\/ \u00b7 \/resources\/ \u00b7 \/contact\/\n   ============================================================ -->\n\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"BreadcrumbList\",\n  \"@id\": \"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/#breadcrumb\",\n  \"itemListElement\": [\n    {\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/seamlessbio.de\/\"},\n    {\"@type\":\"ListItem\",\"position\":2,\"name\":\"Blog\",\"item\":\"https:\/\/seamlessbio.de\/blog\/\"},\n    {\"@type\":\"ListItem\",\"position\":3,\"name\":\"Human Serum for ATMP Manufacturing: GMP Requirements\",\"item\":\"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/\"}\n  ]\n}\n<\/script>\n\n\n\n<style>\n.sb-bphs1-hero{background:linear-gradient(135deg,#18b7b2 0%,#0d9490 100%);border-radius:12px;padding:48px 40px;margin-bottom:36px}\n.sb-bphs1-hero h1{color:#fff!important;font-size:2rem;font-weight:700;line-height:1.25;margin:0 0 14px 0}\n.sb-bphs1-hero .meta{font-size:.8rem;color:rgba(255,255,255,.75)!important;margin:0 0 18px 0;text-transform:uppercase;letter-spacing:.03em}\n.sb-bphs1-hero p{color:rgba(255,255,255,.95)!important;font-size:1.1rem;line-height:1.65;max-width:720px;margin:0}\n.sb-bphs1-card{background:#fff;border:1px solid #e8f7f7;border-radius:10px;padding:36px 40px;margin-bottom:28px}\n.sb-bphs1-card h2{font-size:1.35rem;font-weight:700;color:#0e1c2a;margin:0 0 16px 0}\n.sb-bphs1-card h3{font-size:1.05rem;font-weight:600;color:#18b7b2;margin:22px 0 10px 0}\n.sb-bphs1-card p{color:#374151;line-height:1.7;margin:0 0 14px 0}\n.sb-bphs1-card p:last-child{margin-bottom:0}\n.sb-bphs1-hl{background:#f0faf9;border-left:4px solid #18b7b2;border-radius:0 8px 8px 0;padding:20px 24px;margin:24px 0;color:#1a3a3a;line-height:1.65}\n.sb-bphs1-hl strong{color:#0d9490}\n.sb-bphs1-list{list-style:none;padding:0;margin:0 0 14px 0}\n.sb-bphs1-list li{padding:6px 0 6px 28px;position:relative;color:#374151;line-height:1.6}\n.sb-bphs1-list li::before{content:\"\u2713\";position:absolute;left:0;color:#18b7b2;font-weight:700}\n.sb-bphs1-table-wrap{overflow-x:auto;margin:16px 0}\n.sb-bphs1-table{width:100%;border-collapse:collapse;font-size:.92rem}\n.sb-bphs1-table th{background:#18b7b2;color:#fff!important;padding:11px 16px;text-align:left;font-weight:600}\n.sb-bphs1-table td{padding:10px 16px;border-bottom:1px solid #e8f7f7;color:#374151;vertical-align:top}\n.sb-bphs1-table tr:nth-child(even) td{background:#f4fefe}\n.sb-bphs1-cta{background:#18b7b2;border-radius:12px;padding:40px;text-align:center;margin-bottom:28px}\n.sb-bphs1-cta h2{color:#fff!important;font-size:1.5rem;font-weight:700;margin:0 0 12px 0}\n.sb-bphs1-cta p{color:rgba(255,255,255,.9)!important;margin:0 0 24px 0}\n.sb-bphs1-cta a.btn{display:inline-block;background:#fff;color:#18b7b2!important;font-weight:700;padding:14px 32px;border-radius:8px;text-decoration:none;font-size:1rem;margin:0 8px 8px 8px}\n.sb-bphs1-cta a.btn:hover{opacity:.88}\n.sb-bphs1-cta a.outline{background:transparent;color:#fff!important;border:2px solid rgba(255,255,255,.8)}\n.sb-bphs1-faq{margin-bottom:28px}\n.sb-bphs1-faq h2{font-size:1.35rem;font-weight:700;color:#0e1c2a;margin:0 0 20px 0}\n.sb-bphs1-faq details{border:1px solid #e8f7f7;border-radius:8px;margin-bottom:10px}\n.sb-bphs1-faq summary{background:#f9fdfd;padding:16px 44px 16px 20px;font-weight:600;color:#0e1c2a;cursor:pointer;list-style:none;position:relative}\n.sb-bphs1-faq summary::after{content:\"+\";position:absolute;right:20px;top:50%;transform:translateY(-50%);font-size:1.3rem;color:#18b7b2;font-weight:300}\n.sb-bphs1-faq details[open] summary::after{content:\"\u2212\"}\n.sb-bphs1-faq details[open] summary{background:#e8f7f7}\n.sb-bphs1-faq .body{padding:16px 20px;color:#374151;line-height:1.7}\n@media(max-width:680px){.sb-bphs1-hero{padding:32px 20px}.sb-bphs1-hero h1{font-size:1.55rem}.sb-bphs1-card{padding:24px 20px}.sb-bphs1-cta{padding:28px 20px}}\n<\/style>\n<div class=\"sb-bphs1-hero\">\n  <p class=\"meta\">Blog \u00b7 Human Serum \u00b7 ATMP \u00b7 GMP \u00b7 October 2026 \u00b7 8 min read<\/p>\n  <h1>Human Serum for ATMP Manufacturing: GMP Requirements, Donor Screening and Lot Qualification<\/h1>\n  <p>ATMP and cell therapy manufacturing increasingly demands xeno-free, human-derived raw materials. Human serum \u2014 when correctly qualified \u2014 meets that requirement. This guide covers what the EU regulatory framework requires, what to look for in a supplier, and how to qualify a lot for GMP use.<\/p>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Why ATMP Manufacturers Are Moving Away from FBS<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The shift from FBS to human-derived supplements in cell therapy manufacturing is no longer just a scientific preference \u2014 it is a regulatory direction. EMA&#8217;s guideline on advanced therapy medicinal products (Guideline on human cell-based medicinal products, EMA\/CHMP\/410869\/2008) and the current EU GMP Annex 2 for ATMPs both encourage the elimination of animal-derived materials from manufacturing processes where technically feasible, citing risks of xenogeneic contamination, immune reactions in recipients, and supply chain inconsistency.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For many ATMP applications \u2014 T-cell expansion, CAR-T manufacturing, MSC culture, NK cell production \u2014 human serum or human platelet lysate (hPL) can replace FBS at equivalent or superior cell yield and phenotype, while satisfying the xeno-free requirement that regulators and clinical sponsors increasingly expect in IND\/IMPD submissions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Human Serum Offers in ATMP Manufacturing<\/h2>\n\n\n\n<div class=\"sb-bphs1-table-wrap\">\n  <table class=\"sb-bphs1-table\">\n    <thead>\n      <tr><th>Parameter<\/th><th>FBS<\/th><th>Human Serum (AB type)<\/th><\/tr>\n    <\/thead>\n    <tbody>\n      <tr><td>Species origin<\/td><td>Bovine \u2014 xenogeneic<\/td><td>Human \u2014 species-matched<\/td><\/tr>\n      <tr><td>Xeno-free status<\/td><td>No<\/td><td>Yes<\/td><\/tr>\n      <tr><td>ABO antibody interference<\/td><td>Not applicable<\/td><td>Absent in AB type (no anti-A, anti-B)<\/td><\/tr>\n      <tr><td>T-cell \/ NK expansion support<\/td><td>Suboptimal \u2014 xenogeneic immune activation risk<\/td><td>Optimal \u2014 physiological context for human immune cells<\/td><\/tr>\n      <tr><td>Regulatory acceptance (ATMP\/GMP)<\/td><td>Discouraged where alternatives exist<\/td><td>Supported \u2014 aligns with xeno-free guidance<\/td><\/tr>\n      <tr><td>Viral safety testing<\/td><td>Bovine virus panel required<\/td><td>Human donor screening: HIV, HCV, HBV, syphilis, NAT<\/td><\/tr>\n      <tr><td>Lot-to-lot consistency<\/td><td>Variable \u2014 biological origin<\/td><td>Improved with pooled multi-donor lots (\u226520 donors)<\/td><\/tr>\n    <\/tbody>\n  <\/table>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">GMP Requirements for Human Serum as a Raw Material<\/h2>\n\n\n\n<div class=\"sb-bphs1-card\">\n  <h3>Donor screening and viral safety<\/h3>\n  <p>Human serum used in GMP manufacturing must originate from donors screened according to the EU Blood Directive (2002\/98\/EC and technical Directives 2004\/33\/EC, 2005\/61\/EC, 2005\/62\/EC). Mandatory screening includes serological and NAT (nucleic acid testing) for HIV-1\/2, HCV, HBV, and syphilis. The supplier must provide documented evidence of donor screening per lot, not just a blanket statement.<\/p>\n\n  <h3>Certificate of Analysis \u2014 minimum contents for ATMP use<\/h3>\n  <ul class=\"sb-bphs1-list\">\n    <li>Lot number, collection date, and processing date<\/li>\n    <li>Donor pool composition (number of donors, blood group where applicable)<\/li>\n    <li>Viral screening results (HIV, HCV, HBV, syphilis) \u2014 per lot, not per process<\/li>\n    <li>Sterility result (USP &lt;71&gt; or Ph. Eur. 2.6.1 method)<\/li>\n    <li>Mycoplasma test result<\/li>\n    <li>Endotoxin (LAL) \u2014 typically &lt;5 EU\/mL or &lt;1 EU\/mL for critical applications<\/li>\n    <li>Total protein concentration<\/li>\n    <li>Haemoglobin content<\/li>\n    <li>Country of origin and blood collection centre identity<\/li>\n  <\/ul>\n\n  <h3>Blood type: why AB serum is the only viable choice for ATMP<\/h3>\n  <p>Human serum from blood type AB donors contains no anti-A or anti-B antibodies. This is essential for ATMP manufacturing: any serum containing ABO antibodies will react with cell surface antigens on non-matched donor cells, causing complement-mediated cytotoxicity. AB serum is the universal format \u2014 it is compatible with cells from donors of any blood type, which is a prerequisite for allogeneic ATMP manufacturing platforms.<\/p>\n\n  <h3>Heat inactivation and other processing treatments<\/h3>\n  <p>Heat inactivation (56 \u00b0C, 30 min) destroys complement activity, which is often specified for T-cell and NK cell expansion protocols where residual complement could impair cell viability. Gamma-irradiated human serum provides an additional viral safety margin and is required in some sponsor protocols. Both treatments must be documented in the CoA with process parameters and acceptance criteria.<\/p>\n\n  <h3>TSE \/ prion safety documentation<\/h3>\n  <p>While human serum does not carry the same TSE risk profile as bovine-derived materials, the Regulatory Master File (dossier) for your ATMP product will require a risk assessment for all human-derived raw materials covering variant CJD (vCJD). Your supplier must provide a TSE\/BSE declaration and, where applicable, documentation of donor selection criteria that exclude individuals from vCJD risk populations (EMA\/410\/01 Rev. 3 applies).<\/p>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Lot Qualification Workflow for GMP Human Serum<\/h2>\n\n\n\n<div class=\"sb-bphs1-card\">\n  <h2>From supplier CoA to approved GMP lot<\/h2>\n  <ul class=\"sb-bphs1-list\">\n    <li>Obtain full supplier documentation package: CoA, CoO, donor screening records, TSE declaration, sterility certificate<\/li>\n    <li>Review supplier qualification status \u2014 ISO 13485 certification or equivalent quality management system for medical-grade biological materials<\/li>\n    <li>Receive a small evaluation volume (50\u2013200 mL); run incoming QC: visual inspection, pH, sterility, endotoxin (LAL), mycoplasma PCR<\/li>\n    <li>Run cell-based performance qualification: expand your target cell type (T cells, NK cells, MSCs) in media supplemented with test lot vs. reference lot; assess viability, expansion fold, and phenotype markers<\/li>\n    <li>For allogeneic ATMP: confirm AB type and absence of anti-A\/anti-B antibodies via agglutination test if not specified by supplier<\/li>\n    <li>Review results against your internal acceptance specification; create lot qualification report for the batch record<\/li>\n    <li>Reserve the bulk lot; document lot number and reserved quantity in your raw material inventory system<\/li>\n  <\/ul>\n<\/div>\n\n\n\n<div class=\"sb-bphs1-hl\">\n  <strong>Practical note:<\/strong> For Phase I\/II ATMP development, full GMP raw material qualification can be iterative \u2014 start with a documented risk-based approach and scale the qualification package as the programme advances toward Phase III or commercial manufacturing. EMA expects qualification to be appropriate to the phase of development, not necessarily to commercial standards from day one.\n<\/div>\n\n\n\n<div class=\"sb-bphs1-cta\">\n  <h2>GMP-Compatible Human Serum AB \u2014 EU Origin, Full Documentation<\/h2>\n  <p>Human serum Type AB (off-the-clot, heat-inactivated, gamma-irradiated options) from certified EU donor centres. Full CoA per lot \u2014 viral screening, sterility, endotoxin, mycoplasma. No minimum order quantity.<\/p>\n  <a href=\"https:\/\/seamlessbio.de\/human-sera-plasma-and-more\/\" class=\"btn\">View Human Serum Portfolio<\/a>\n  <a href=\"https:\/\/seamlessbio.de\/contact\/\" class=\"btn outline\">Request Documentation Package<\/a>\n<\/div>\n\n\n\n<div class=\"sb-bphs1-faq\">\n  <h2>Frequently Asked Questions<\/h2>\n  <details><summary>Can human serum replace FBS in CAR-T cell manufacturing?<\/summary><div class=\"body\">Yes \u2014 human AB serum is widely used as an FBS replacement in CAR-T cell expansion protocols. It provides a xeno-free, species-matched environment that supports T-cell proliferation and phenotype maintenance without the xenogeneic immune activation risk associated with FBS. Some protocols specify human platelet lysate (hPL) instead of or in addition to human serum, particularly for GMP-grade clinical manufacturing. SeamlessBio supplies both human serum AB and hPL for evaluation.<\/div><\/details>\n  <details><summary>Which blood type of human serum is required for ATMP manufacturing?<\/summary><div class=\"body\">Type AB is the only appropriate blood type for ATMP manufacturing. AB donors carry neither anti-A nor anti-B antibodies, making AB serum compatible with cells from donors of any blood type. Using A, B or O serum in allogeneic manufacturing would introduce ABO antibody-mediated cytotoxicity risk against the patient&#8217;s cells.<\/div><\/details>\n  <details><summary>What is the difference between off-the-clot and heat-inactivated human serum for ATMP?<\/summary><div class=\"body\">Off-the-clot human serum retains full complement activity, which may be beneficial for some assays but is typically undesirable in ATMP cell expansion due to complement-mediated cytotoxicity against expanded cells. Heat-inactivated human serum (56 \u00b0C, 30 min) has complement activity eliminated and is the standard specification for T-cell, NK cell and MSC expansion protocols in ATMP manufacturing.<\/div><\/details>\n  <details><summary>Does human serum require a TSE\/BSE statement for ATMP use?<\/summary><div class=\"body\">Yes. Although human-derived materials do not carry bovine TSE risk, the EMA guideline on minimising the risk of transmitting animal spongiform encephalopathy agents (EMA\/410\/01 Rev. 3) and ATMP-specific guidance both require a risk assessment for all human-derived raw materials regarding variant CJD. Your supplier should provide a declaration covering donor selection criteria and vCJD exclusion measures.<\/div><\/details>\n  <details><summary>How many donors should a human serum pool contain for GMP use?<\/summary><div class=\"body\">Pooled lots from \u226520 donors are standard for IVD and research-grade applications. For GMP ATMP manufacturing, pool size requirements depend on your risk assessment and sponsor agreement \u2014 larger pools (50\u2013100+ donors) provide better lot-to-lot consistency and reduce the statistical impact of a single donor outlier, but require more extensive viral screening documentation. SeamlessBio can supply pooled lots with a defined minimum donor count on request.<\/div><\/details>\n<\/div>\n\n\n\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\"@type\":\"Question\",\"name\":\"Can human serum replace FBS in CAR-T cell manufacturing?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes \u2014 human AB serum is widely used as an FBS replacement in CAR-T cell expansion protocols. It provides a xeno-free, species-matched environment that supports T-cell proliferation and phenotype maintenance without the xenogeneic immune activation risk associated with FBS.\"}},\n    {\"@type\":\"Question\",\"name\":\"Which blood type of human serum is required for ATMP manufacturing?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Type AB is the only appropriate blood type for ATMP manufacturing. AB donors carry neither anti-A nor anti-B antibodies, making AB serum compatible with cells from donors of any blood type.\"}},\n    {\"@type\":\"Question\",\"name\":\"What is the difference between off-the-clot and heat-inactivated human serum for ATMP?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Heat-inactivated human serum (56 \u00b0C, 30 min) has complement activity eliminated and is the standard specification for T-cell, NK cell and MSC expansion protocols in ATMP manufacturing. Off-the-clot serum retains complement activity, which is typically undesirable in cell expansion.\"}},\n    {\"@type\":\"Question\",\"name\":\"Does human serum require a TSE\/BSE statement for ATMP use?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. EMA guidance requires a risk assessment for all human-derived raw materials regarding variant CJD. Your supplier should provide a declaration covering donor selection criteria and vCJD exclusion measures.\"}},\n    {\"@type\":\"Question\",\"name\":\"How many donors should a human serum pool contain for GMP use?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Pooled lots from \u226520 donors are standard. For GMP ATMP manufacturing, larger pools (50\u2013100+ donors) provide better lot-to-lot consistency. SeamlessBio can supply pooled lots with a defined minimum donor count on request.\"}}\n  ]\n}\n<\/script>\n","protected":false},"excerpt":{"rendered":"<p>Blog \u00b7 Human Serum \u00b7 ATMP \u00b7 GMP \u00b7 October 2026 \u00b7 8 min read Human Serum for ATMP Manufacturing: GMP Requirements, Donor Screening and Lot Qualification ATMP and cell therapy manufacturing increasingly demands xeno-free, human-derived raw materials. Human serum \u2014 when correctly qualified \u2014 meets that requirement. This guide covers what the EU regulatory [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-9121","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Human Serum for ATMP Manufacturing: GMP Requirements<\/title>\n<meta name=\"description\" content=\"GMP-grade human serum for ATMP and cell therapy manufacturing \u2014 donor screening, viral safety, lot qualification, and EU regulatory requirements.\" \/>\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\/human-serum-atmp-manufacturing-gmp\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Human Serum for ATMP Manufacturing: GMP Requirements\" \/>\n<meta property=\"og:description\" content=\"GMP-grade human serum for ATMP and cell therapy manufacturing \u2014 donor screening, viral safety, lot qualification, and EU regulatory requirements.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/seamlessbio.de\/de\/human-serum-atmp-manufacturing-gmp\/\" \/>\n<meta property=\"og:site_name\" content=\"SeamlessBio\" \/>\n<meta property=\"article:published_time\" content=\"2026-09-30T16:54:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-10-20T09:41:44+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046.png\" \/>\n\t<meta property=\"og:image:width\" content=\"973\" \/>\n\t<meta property=\"og:image:height\" content=\"288\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Verfasst von\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data2\" content=\"6\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#\\\/schema\\\/person\\\/380871817f00a1e16eccbe7585a20c17\"},\"headline\":\"Human Serum for ATMP\",\"datePublished\":\"2026-09-30T16:54:52+00:00\",\"dateModified\":\"2026-10-20T09:41:44+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/\"},\"wordCount\":1220,\"publisher\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#organization\"},\"articleSection\":[\"Uncategorized\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/\",\"name\":\"Human Serum for ATMP Manufacturing: GMP Requirements\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\"},\"datePublished\":\"2026-09-30T16:54:52+00:00\",\"dateModified\":\"2026-10-20T09:41:44+00:00\",\"description\":\"GMP-grade human serum for ATMP and cell therapy manufacturing \u2014 donor screening, viral safety, lot qualification, and EU regulatory requirements.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\\\/\\\/seamlessbio.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Uncategorized\",\"item\":\"https:\\\/\\\/seamlessbio.de\\\/category\\\/uncategorized\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Human Serum for ATMP\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/\",\"name\":\"SeamlessBio\",\"description\":\"Human serum, plasma and hPL, single-use bioprocessing bags, serum-free media, animal sera and FBS. EU stock, lot reservation up to 36 months, no minimum order.\",\"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\\\/human-serum-atmp-manufacturing-gmp\\\/#local-main-organization-logo\"},\"image\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/#local-main-organization-logo\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/company\\\/seamlessbio\\\/\",\"https:\\\/\\\/seamlessbio.ch\\\/\"],\"address\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/#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\":\"Person\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#\\\/schema\\\/person\\\/380871817f00a1e16eccbe7585a20c17\",\"name\":\"admin\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c82349c4c3fd3df1cfbb69d5f386d959a89ab4c9dcec1e7889a5140df2c0f1a0?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c82349c4c3fd3df1cfbb69d5f386d959a89ab4c9dcec1e7889a5140df2c0f1a0?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/c82349c4c3fd3df1cfbb69d5f386d959a89ab4c9dcec1e7889a5140df2c0f1a0?s=96&d=mm&r=g\",\"caption\":\"admin\"},\"sameAs\":[\"https:\\\/\\\/seamlessbio.de\"],\"url\":\"https:\\\/\\\/seamlessbio.de\\\/de\\\/author\\\/admin\\\/\"},{\"@type\":\"PostalAddress\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-serum-atmp-manufacturing-gmp\\\/#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\\\/human-serum-atmp-manufacturing-gmp\\\/#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":"Humanserum f\u00fcr die ATMP-Herstellung: GMP-Anforderungen","description":"Humanserum in GMP-Qualit\u00e4t f\u00fcr die Herstellung von ATMP und Zelltherapeutika \u2013 Spenderscreening, Virussicherheit, Chargenqualifizierung und regulatorische Anforderungen in der EU.","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\/human-serum-atmp-manufacturing-gmp\/","og_locale":"de_DE","og_type":"article","og_title":"Human Serum for ATMP Manufacturing: GMP Requirements","og_description":"GMP-grade human serum for ATMP and cell therapy manufacturing \u2014 donor screening, viral safety, lot qualification, and EU regulatory requirements.","og_url":"https:\/\/seamlessbio.de\/de\/human-serum-atmp-manufacturing-gmp\/","og_site_name":"SeamlessBio","article_published_time":"2026-09-30T16:54:52+00:00","article_modified_time":"2026-10-20T09:41:44+00:00","og_image":[{"width":973,"height":288,"url":"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046.png","type":"image\/png"}],"author":"admin","twitter_card":"summary_large_image","twitter_misc":{"Verfasst von":"admin","Gesch\u00e4tzte Lesezeit":"6\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/#article","isPartOf":{"@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/"},"author":{"name":"admin","@id":"https:\/\/seamlessbio.de\/#\/schema\/person\/380871817f00a1e16eccbe7585a20c17"},"headline":"Human Serum for ATMP","datePublished":"2026-09-30T16:54:52+00:00","dateModified":"2026-10-20T09:41:44+00:00","mainEntityOfPage":{"@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/"},"wordCount":1220,"publisher":{"@id":"https:\/\/seamlessbio.de\/#organization"},"articleSection":["Uncategorized"],"inLanguage":"de"},{"@type":"WebPage","@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/","url":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/","name":"Humanserum f\u00fcr die ATMP-Herstellung: GMP-Anforderungen","isPartOf":{"@id":"https:\/\/seamlessbio.de\/#website"},"datePublished":"2026-09-30T16:54:52+00:00","dateModified":"2026-10-20T09:41:44+00:00","description":"Humanserum in GMP-Qualit\u00e4t f\u00fcr die Herstellung von ATMP und Zelltherapeutika \u2013 Spenderscreening, Virussicherheit, Chargenqualifizierung und regulatorische Anforderungen in der EU.","breadcrumb":{"@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/#breadcrumb"},"inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Start","item":"https:\/\/seamlessbio.de\/"},{"@type":"ListItem","position":2,"name":"Uncategorized","item":"https:\/\/seamlessbio.de\/category\/uncategorized\/"},{"@type":"ListItem","position":3,"name":"Human Serum for ATMP"}]},{"@type":"WebSite","@id":"https:\/\/seamlessbio.de\/#website","url":"https:\/\/seamlessbio.de\/","name":"SeamlessBio","description":"Humanserum, Plasma und hPL, Single-Use-Bioprozessbeutel, serumfreie Medien, Tierseren und FKS. EU-Lager, Chargenreservierung bis 36 Monate, ohne Mindestmenge.","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\/human-serum-atmp-manufacturing-gmp\/#local-main-organization-logo"},"image":{"@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/#local-main-organization-logo"},"sameAs":["https:\/\/www.linkedin.com\/company\/seamlessbio\/","https:\/\/seamlessbio.ch\/"],"address":{"@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/#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":"Person","@id":"https:\/\/seamlessbio.de\/#\/schema\/person\/380871817f00a1e16eccbe7585a20c17","name":"admin","image":{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/secure.gravatar.com\/avatar\/c82349c4c3fd3df1cfbb69d5f386d959a89ab4c9dcec1e7889a5140df2c0f1a0?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/c82349c4c3fd3df1cfbb69d5f386d959a89ab4c9dcec1e7889a5140df2c0f1a0?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/c82349c4c3fd3df1cfbb69d5f386d959a89ab4c9dcec1e7889a5140df2c0f1a0?s=96&d=mm&r=g","caption":"admin"},"sameAs":["https:\/\/seamlessbio.de"],"url":"https:\/\/seamlessbio.de\/de\/author\/admin\/"},{"@type":"PostalAddress","@id":"https:\/\/seamlessbio.de\/human-serum-atmp-manufacturing-gmp\/#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\/human-serum-atmp-manufacturing-gmp\/#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\/posts\/9121","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/types\/post"}],"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=9121"}],"version-history":[{"count":1,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/posts\/9121\/revisions"}],"predecessor-version":[{"id":9122,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/posts\/9121\/revisions\/9122"}],"wp:attachment":[{"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/media?parent=9121"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/categories?post=9121"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/seamlessbio.de\/de\/wp-json\/wp\/v2\/tags?post=9121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}