{"id":3378,"date":"2026-09-02T09:08:35","date_gmt":"2026-09-02T08:08:35","guid":{"rendered":"https:\/\/seamlessbio.de\/?page_id=3378"},"modified":"2026-09-02T09:10:25","modified_gmt":"2026-09-02T08:10:25","slug":"simplacecdx-hek293-chemically-defined-medium","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/simplacecdx-hek293-chemically-defined-medium\/","title":{"rendered":"SimplaceCDX"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"3378\" class=\"elementor elementor-3378\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7d3abd8 e-con e-atomic-element e-flexbox-base e-6723a43\" data-id=\"7d3abd8\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"7d3abd8\">\n    \t\t<div class=\"elementor-element elementor-element-f2b72d6 elementor-widget elementor-widget-html\" data-id=\"f2b72d6\" data-element_type=\"widget\" data-e-type=\"widget\" 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.rg{grid-template-columns:repeat(2,1fr)}}\n@media(max-width:600px){.sb-sfm{padding:26px 14px 56px}.sb-sfm .hero{padding:32px 20px}.sb-sfm h1{font-size:26px}.sb-sfm .strip,.sb-sfm .grid,.sb-sfm .rg{grid-template-columns:1fr}.sb-sfm .step{grid-template-columns:1fr}.sb-sfm .cta{padding:28px 20px}}\n<\/style>\n\n<div class=\"sb-sfm\">\n\n<div class=\"bc\">\n  <a href=\"https:\/\/seamlessbio.de\/de\/\">Startseite<\/a><span>\/<\/span>\n  <a href=\"https:\/\/seamlessbio.de\/de\/produkte\/\">Produkte<\/a><span>\/<\/span>\n  <a href=\"https:\/\/seamlessbio.de\/de\/zellkultur\/\">Zellkulturmedien<\/a><span>\/<\/span>\n  <a href=\"https:\/\/seamlessbio.de\/de\/serumfreies-medium-hek293\/\">Serumfreies Medium HEK293<\/a><span>\/<\/span>\n  <strong>SimplaceCDX<\/strong> <span class=\"badge badge-new\">NEW<\/span>\n<\/div>\n\n<div class=\"hero\">\n  <span class=\"ey\">Chemically Defined \u00b7 Animal-Origin-Free \u00b7 IND-Enabling \u00b7 GMP Pathway<\/span>\n  <h1>SimplaceCDX \u2014 Chemically Defined Medium for HEK293T<\/h1>\n  <p class=\"sub\">Fully chemically defined, animal-origin-free medium for HEK293T adherent culture \u2014 for IND-enabling and GMP AAV production where CDM documentation is required. No serum, no animal-derived proteins, no recombinant proteins.<\/p>\n  <div class=\"hbtn\">\n    <a class=\"btn\" href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\">Request Sample or Quote<\/a>\n    <a class=\"btn-o\" href=\"https:\/\/seamlessbio.de\/de\/simplacex-hek293-serum-free-medium\/\">SimplaceX \u2014 Start Here<\/a>\n  <\/div>\n<\/div>\n\n<div class=\"strip\">\n  <div class=\"cs\"><b>CDM<\/b><span>Fully chemically defined \u2014 every component known and documented<\/span><\/div>\n  <div class=\"cs\"><b>AOF<\/b><span>Animal-origin-free \u2014 no TSE\/BSE risk, no adventitious agent concern<\/span><\/div>\n  <div class=\"cs\"><b>IND-Ready<\/b><span>CDM documentation for CMC section of IND\/CTA filing<\/span><\/div>\n  <div class=\"cs\"><b>500 mL \/ 2 L<\/b><span>Research and pilot scale \u2014 GMP volumes on request<\/span><\/div>\n<\/div>\n\n<div class=\"warn\">\n  <b>Recommended pathway:<\/b> Adapt HEK293T to <a href=\"https:\/\/seamlessbio.de\/de\/simplacex-hek293-serum-free-medium\/\">SimplaceX<\/a> first (5\u201310 passages), then transition to SimplaceCDX. Direct adaptation from FBS to SimplaceCDX is possible but slower \u2014 typically 10\u201315 passages versus 5\u201310 for SimplaceX. See the full adaptation protocol guide.\n<\/div>\n\n<h2>What is SimplaceCDX?<\/h2>\n<p class=\"lede\">SimplaceCDX is a fully chemically defined (CDM), animal-origin-free cell culture medium for HEK293T adherent culture. Unlike SimplaceX, which contains a defined protein supplement, SimplaceCDX contains no animal-derived or recombinant protein components \u2014 every ingredient is a synthetic small molecule or defined inorganic compound. This is the medium format required when GMP raw material documentation must demonstrate full chemical definition with no animal-derived or protein components.<\/p>\n\n<h2>SimplaceCDX vs. SimplaceX \u2014 Which to Use?<\/h2>\n<div class=\"tw\">\n  <table>\n    <thead><tr><th>Parameter<\/th><th>SimplaceX<\/th><th>SimplaceCDX<\/th><\/tr><\/thead>\n    <tbody>\n      <tr><td>Composition<\/td><td>Serum-free, protein-supplemented<\/td><td>Fully chemically defined \u2014 no proteins<\/td><\/tr>\n      <tr><td>frei von tierischen Bestandteilen<\/td><td>\u2705 No serum<\/td><td>\u2705 No serum, no animal-derived protein<\/td><\/tr>\n      <tr><td>Protein components<\/td><td>Defined protein supplement included<\/td><td>None \u2014 protein-free<\/td><\/tr>\n      <tr><td>GMP raw material risk<\/td><td>Low \u2014 defined, no serum<\/td><td>\u2705 Lowest \u2014 fully defined synthetic\/inorganic components<\/td><\/tr>\n      <tr><td>CDM documentation<\/td><td>Not fully CDM<\/td><td>\u2705 Full CDM documentation available<\/td><\/tr>\n      <tr><td>Adaptation difficulty<\/td><td>Easier \u2014 5\u201310 passages<\/td><td>More demanding \u2014 10\u201315 passages from FBS, or 3\u20135 from SimplaceX<\/td><\/tr>\n      <tr><td>Nachgeschaltete Reinigung<\/td><td>\u2705 No serum protein impurities<\/td><td>\u2705 No protein impurities at all<\/td><\/tr>\n      <tr><td>When to use<\/td><td>Research, pre-clinical, early IND-enabling<\/td><td>IND-enabling where CDM is specified, GMP manufacturing<\/td><\/tr>\n    <\/tbody>\n  <\/table>\n<\/div>\n\n<h2>Why Chemically Defined Medium for GMP AAV?<\/h2>\n<p>All commercially approved AAV gene therapies (Luxturna, Zolgensma, Hemgenix) are manufactured using chemically defined or serum-free medium. Regulatory guidance from FDA (Process Validation: General Principles and Practices) and EMA (Guideline on the quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials) both encourage the use of CDM for ATMP manufacturing \u2014 for three specific reasons:<\/p>\n<ul>\n  <li><strong>Raw material risk:<\/strong> CDM raw materials are synthetic or defined inorganic compounds with no biological variability and no adventitious agent risk \u2014 the highest-risk raw material category (animal-derived biologics) is entirely absent<\/li>\n  <li><strong>Batch-to-batch consistency:<\/strong> CDM has zero compositional variability between production batches \u2014 removing a major source of process variability that must otherwise be demonstrated through extensive historical data<\/li>\n  <li><strong>IND\/CTA CMC documentation:<\/strong> CDM allows a complete list of components to be filed in the Chemistry, Manufacturing and Controls section without \"proprietary blend\" classifications or biological source documentation \u2014 simplifying regulatory review<\/li>\n<\/ul>\n\n<h2>Produktinformationen<\/h2>\n<div class=\"tw\">\n  <table>\n    <thead><tr><th>Parameter<\/th><th>Spezifikation<\/th><\/tr><\/thead>\n    <tbody>\n      <tr><td>Format<\/td><td>Fully chemically defined \u2014 no animal-derived or recombinant protein components<\/td><\/tr>\n      <tr><td>Cell type<\/td><td>HEK293T (adherent) \u2014 also suitable for HEK293, HEK293FT<\/td><\/tr>\n      <tr><td>Hauptanwendung<\/td><td>GMP AAV production, IND-enabling vector manufacturing, lentiviral vector<\/td><\/tr>\n      <tr><td>Volumes available<\/td><td>500 mL, 2,000 mL \u2014 GMP volumes on request<\/td><\/tr>\n      <tr><td>frei von tierischen Bestandteilen<\/td><td>\u2705 Full CDM \u2014 no animal-derived or recombinant protein components<\/td><\/tr>\n      <tr><td>Transfektionsvertr\u00e4glichkeit<\/td><td>PEI (linear 25 kDa), PEI-Max compatible<\/td><\/tr>\n      <tr><td>Sterilit\u00e4t<\/td><td>0.2 \u00b5m sterile filtered \u2014 sterility tested per lot<\/td><\/tr>\n      <tr><td>Lagerung<\/td><td>2\u20138\u00b0C, protected from light \u2014 stable 12 months from manufacture<\/td><\/tr>\n      <tr><td>Dokumentation<\/td><td>Full component list, CoA, CDM declaration \u2014 IMPD-supporting documentation on request<\/td><\/tr>\n      <tr><td>GMP-Signalweg<\/td><td>In Entwicklung \u2013 bitte kontaktieren Sie uns bez\u00fcglich Zeitplan und Anforderungen<\/td><\/tr>\n    <\/tbody>\n  <\/table>\n<\/div>\n\n<h2>Adaptation Protocol \u2014 FBS to SimplaceCDX<\/h2>\n<p><strong>Recommended pathway: FBS \u2192 SimplaceX \u2192 SimplaceCDX<\/strong><\/p>\n\n<div class=\"step\">\n  <div class=\"step-n\">1<\/div>\n  <div>\n    <h3>Phase 1 \u2014 Adapt to SimplaceX (5\u201310 passages)<\/h3>\n    <p>Follow the <a href=\"https:\/\/seamlessbio.de\/de\/ressourcen\/blog\/hek293t-serum-free-adaptation-simplacex\/\">SimplaceX adaptation protocol<\/a>. Complete adaptation confirmed by stable doubling time \u226422h for 3 consecutive passages.<\/p>\n  <\/div>\n<\/div>\n\n<div class=\"step\">\n  <div class=\"step-n\">2<\/div>\n  <div>\n    <h3>Phase 2 \u2014 Transition SimplaceX \u2192 SimplaceCDX (4 passages)<\/h3>\n    <ul>\n      <li>P1: 75% SimplaceX + 25% SimplaceCDX<\/li>\n      <li>P2: 50% SimplaceX + 50% SimplaceCDX<\/li>\n      <li>P3: 25% SimplaceX + 75% SimplaceCDX<\/li>\n      <li>P4+: 100% SimplaceCDX<\/li>\n    <\/ul>\n    <p>Apply the suspension cell rescue protocol at every passage during this phase.<\/p>\n  <\/div>\n<\/div>\n\n<div class=\"step\">\n  <div class=\"step-n\">3<\/div>\n  <div>\n    <h3>Phase 3 \u2014 Confirm adaptation and run AAV production test<\/h3>\n    <p>Stable doubling time \u226424h in 100% SimplaceCDX for 3 consecutive passages \u2192 run small-scale AAV production test (one 15 cm dish) to confirm titre before scale-up.<\/p>\n  <\/div>\n<\/div>\n\n<div class=\"note\">\n  <b>Detachment in SimplaceCDX:<\/b> Use PBS + 5 mM EDTA for cell detachment in SimplaceCDX \u2014 trypsin should be avoided where possible, and if used, must be completely removed by centrifugation before resuspending in SimplaceCDX.\n<\/div>\n\n<div class=\"faq\">\n  <h2>H\u00e4ufig gestellte Fragen<\/h2>\n\n  <p class=\"fq\">Is SimplaceCDX suitable for GMP AAV manufacturing?<\/p>\n  <p>SimplaceCDX is formulated for the GMP pathway \u2014 fully chemically defined, animal-origin-free, with CDM documentation available for IND\/CTA CMC sections. GMP-grade production batches are in development \u2014 contact us for the current timeline and requirements for your specific programme.<\/p>\n\n  <p class=\"fq\">Can I adapt HEK293T directly from FBS to SimplaceCDX?<\/p>\n  <p>Direct adaptation from FBS to SimplaceCDX is possible but typically takes 10\u201315 passages and produces more variability in adaptation outcomes. The recommended pathway is FBS \u2192 SimplaceX (5\u201310 passages) \u2192 SimplaceCDX (4 passages) \u2014 total of 9\u201314 passages for a more stable, faster adaptation.<\/p>\n\n  <p class=\"fq\">What documentation is available for CDM declaration?<\/p>\n  <p>Full component list, Certificate of Analysis, animal-origin-free declaration, and CDM declaration are available. IMPD-supporting documentation package for IND\/CTA submissions available on request \u2014 contact us with your regulatory requirements and timeline.<\/p>\n\n  <p class=\"fq\">Is SimplaceCDX compatible with PEI transfection for AAV production?<\/p>\n  <p>Yes \u2014 SimplaceCDX is optimised for PEI-mediated triple transfection (linear PEI 25 kDa, PEI-Max). The absence of serum proteins removes any potential serum-PEI complex formation that can reduce transfection efficiency in partially-serum-containing media.<\/p>\n<\/div>\n\n<div class=\"rel\">\n  <h2>\u00c4hnliche Produkte &amp; Anleitungen<\/h2>\n  <div class=\"rg\">\n    <a href=\"https:\/\/seamlessbio.de\/de\/simplacex-hek293-serum-free-medium\/\">SimplaceX \u2014 Start with This \u2192<\/a>\n    <a href=\"https:\/\/seamlessbio.de\/de\/serumfreies-medium-hek293\/\">All HEK293 Serum-Free Media \u2192<\/a>\n    <a href=\"https:\/\/seamlessbio.de\/de\/ressourcen\/blog\/hek293t-serum-free-adaptation-simplacex\/\">Adaptation Protocol Guide \u2192<\/a>\n    <a href=\"https:\/\/seamlessbio.de\/de\/ressourcen\/blog\/fbs-vs-serum-free-aav-production-when-to-switch\/\">FBS vs Serum-Free \u2014 When to Switch \u2192<\/a>\n    <a href=\"https:\/\/seamlessbio.de\/de\/what-is-chemically-defined-medium\/\">What is Chemically Defined Medium? \u2192<\/a>\n    <a href=\"https:\/\/seamlessbio.de\/de\/what-is-atmp\/\">What is ATMP? \u2192<\/a>\n  <\/div>\n<\/div>\n\n<div class=\"cta\">\n  <h2>Request SimplaceCDX \u2014 Sample or Quote<\/h2>\n  <p>500 mL and 2,000 mL available. Full CDM documentation. Free test sample for adaptation evaluation. GMP volumes on request.<\/p>\n  <div class=\"hbtn\" style=\"justify-content:center\">\n    <a class=\"btn\" href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\">Request Sample or Quote<\/a>\n    <a class=\"btn-o\" href=\"mailto:info@seamlessbio.de?subject=SimplaceCDX%20Sample%20Request\">info@seamlessbio.de<\/a>\n  <\/div>\n<\/div>\n\n<\/div>\t\t\t\t<\/div>\n\t\t\n<\/div>\n\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Home\/ Products\/ Cell Culture Media\/ Serum-Free Media HEK293\/ SimplaceCDX NEW Chemically Defined \u00b7 Animal-Origin-Free \u00b7 IND-Enabling \u00b7 GMP Pathway SimplaceCDX \u2014 Chemically Defined Medium for HEK293T Fully chemically defined, animal-origin-free [&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-3378","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is 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