SimplaceCDX — Chemically Defined Medium for HEK293T
Fully chemically defined, animal-origin-free medium for HEK293T adherent culture — for IND-enabling and GMP AAV production where CDM documentation is required. No serum, no animal-derived proteins, no recombinant proteins.
What is SimplaceCDX?
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 — 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.
SimplaceCDX vs. SimplaceX — Which to Use?
| Parameter | SimplaceX | SimplaceCDX |
|---|---|---|
| Composition | Serum-free, protein-supplemented | Fully chemically defined — no proteins |
| frei von tierischen Bestandteilen | ✅ No serum | ✅ No serum, no animal-derived protein |
| Protein components | Defined protein supplement included | None — protein-free |
| GMP raw material risk | Low — defined, no serum | ✅ Lowest — fully defined synthetic/inorganic components |
| CDM documentation | Not fully CDM | ✅ Full CDM documentation available |
| Adaptation difficulty | Easier — 5–10 passages | More demanding — 10–15 passages from FBS, or 3–5 from SimplaceX |
| Nachgeschaltete Reinigung | ✅ No serum protein impurities | ✅ No protein impurities at all |
| When to use | Research, pre-clinical, early IND-enabling | IND-enabling where CDM is specified, GMP manufacturing |
Why Chemically Defined Medium for GMP AAV?
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 — for three specific reasons:
- Raw material risk: CDM raw materials are synthetic or defined inorganic compounds with no biological variability and no adventitious agent risk — the highest-risk raw material category (animal-derived biologics) is entirely absent
- Batch-to-batch consistency: CDM has zero compositional variability between production batches — removing a major source of process variability that must otherwise be demonstrated through extensive historical data
- IND/CTA CMC documentation: 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 — simplifying regulatory review
Produktinformationen
| Parameter | Spezifikation |
|---|---|
| Format | Fully chemically defined — no animal-derived or recombinant protein components |
| Cell type | HEK293T (adherent) — also suitable for HEK293, HEK293FT |
| Hauptanwendung | GMP AAV production, IND-enabling vector manufacturing, lentiviral vector |
| Volumes available | 500 mL, 2,000 mL — GMP volumes on request |
| frei von tierischen Bestandteilen | ✅ Full CDM — no animal-derived or recombinant protein components |
| Transfektionsverträglichkeit | PEI (linear 25 kDa), PEI-Max compatible |
| Sterilität | 0.2 µm sterile filtered — sterility tested per lot |
| Lagerung | 2–8°C, protected from light — stable 12 months from manufacture |
| Dokumentation | Full component list, CoA, CDM declaration — IMPD-supporting documentation on request |
| GMP-Signalweg | In Entwicklung – bitte kontaktieren Sie uns bezüglich Zeitplan und Anforderungen |
Adaptation Protocol — FBS to SimplaceCDX
Recommended pathway: FBS → SimplaceX → SimplaceCDX
Phase 1 — Adapt to SimplaceX (5–10 passages)
Follow the SimplaceX adaptation protocol. Complete adaptation confirmed by stable doubling time ≤22h for 3 consecutive passages.
Phase 2 — Transition SimplaceX → SimplaceCDX (4 passages)
- P1: 75% SimplaceX + 25% SimplaceCDX
- P2: 50% SimplaceX + 50% SimplaceCDX
- P3: 25% SimplaceX + 75% SimplaceCDX
- P4+: 100% SimplaceCDX
Apply the suspension cell rescue protocol at every passage during this phase.
Phase 3 — Confirm adaptation and run AAV production test
Stable doubling time ≤24h in 100% SimplaceCDX for 3 consecutive passages → run small-scale AAV production test (one 15 cm dish) to confirm titre before scale-up.
Häufig gestellte Fragen
Is SimplaceCDX suitable for GMP AAV manufacturing?
SimplaceCDX is formulated for the GMP pathway — fully chemically defined, animal-origin-free, with CDM documentation available for IND/CTA CMC sections. GMP-grade production batches are in development — contact us for the current timeline and requirements for your specific programme.
Can I adapt HEK293T directly from FBS to SimplaceCDX?
Direct adaptation from FBS to SimplaceCDX is possible but typically takes 10–15 passages and produces more variability in adaptation outcomes. The recommended pathway is FBS → SimplaceX (5–10 passages) → SimplaceCDX (4 passages) — total of 9–14 passages for a more stable, faster adaptation.
What documentation is available for CDM declaration?
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 — contact us with your regulatory requirements and timeline.
Is SimplaceCDX compatible with PEI transfection for AAV production?
Yes — 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.
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Request SimplaceCDX — Sample or Quote
500 mL and 2,000 mL available. Full CDM documentation. Free test sample for adaptation evaluation. GMP volumes on request.
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