Beschreibung
Product Overview
SimplaceCDX – Chemically Defined Medium for HEK293T is a fully chemically defined, animal-origin-free cell culture medium engineered for high-yield transient transfection, stable expression, and viral vector manufacturing in HEK293 and HEK293T cell lines.
Every component is precisely specified — no undefined protein fractions, no animal-derived ingredients — making SimplaceCDX the medium of choice for GMP bioprocessing where a complete CDM (chemically defined medium) is required in regulatory documentation (IND, CTA, BLA). Available from SeamlessBio with full CDM documentation, batch reservation, and EU & Swiss supply. Explore our full cell culture media portfolio or visit the SimplaceCDX product page.
SimplaceCDX: Specifications
- Type: Fully chemically defined medium (CDM) — animal-origin-free, no undefined protein fractions
- Cell lines: HEK293, HEK293T — optimised for transient and stable expression
- Adaptation: Recommended via SimplaceX (serum-free bridge): FBS → SimplaceX (5–10 passages) → SimplaceCDX (4 passages)
- Sterility: Sterile filtered, mycoplasma tested
- Storage: 2–8 °C (protect from light)
- Documentation: Full CDM documentation, CoA, sterility certificate — suitable for IND/CTA CMC sections
Anwendungen
- GMP viral vector manufacturing — AAV and lentivirus production in HEK293T-based systems
- Transient transfection for recombinant protein and antibody production requiring CDM documentation
- ATMP and gene therapy process development where animal-origin-free media are mandated
- Stable cell line development and selection under fully defined conditions
- Regulatory submissions (IND, CTA, BLA) requiring complete characterisation of all medium components — see our full cell culture portfolio
Available Formats
| Format | Size |
|---|---|
| Bottle | 500 mL |
| Bottle | 2000 mL |
Key Benefits
Sammelreservierung
Reserve validated lots up to 36 months for reproducible long-term workflows.
Vollständige Dokumentation
CoA, BSE/TSE, sterility certificate — supplied by ISO 9001 and ISO 13485 certified partner facilities. Additional documents on request.
EU & Swiss Supply
Sourced from certified EU and Swiss partner facilities — fast delivery across EU, UK and Switzerland, full documentation included.
Häufig gestellte Fragen
What does “chemically defined” mean and why does it matter for GMP manufacturing?
A chemically defined medium (CDM) contains only components whose identity, purity, and concentration are precisely known and specified. Unlike serum-containing or protein-supplemented media, a CDM has no undefined animal-derived fractions. This is essential for GMP manufacturing: regulatory agencies (EMA, FDA) require full characterisation of all raw materials used in ATMP and viral vector production. SimplaceCDX provides the CDM documentation required for IND, CTA, and BLA submissions.
Is SimplaceCDX suitable for GMP AAV manufacturing in HEK293T cells?
Yes — SimplaceCDX is fully chemically defined and animal-origin-free, making it directly applicable to GMP AAV manufacturing in HEK293T-based triple or quadruple transfection systems. Its CDM documentation supports CMC sections in IND and CTA filings. For research-scale or process development work not requiring full CDM documentation, SimplaceX is the recommended starting point.
Can I adapt HEK293T cells directly from FBS to SimplaceCDX?
Direct adaptation from FBS to SimplaceCDX is not recommended, as the large compositional change typically results in reduced viability and extended recovery. The validated pathway is: FBS → SimplaceX (5–10 passages, stepwise FBS reduction) → SimplaceCDX (4 passages). This two-step protocol consistently achieves >95% viability in 100% SimplaceCDX within 14 passages total.
What documentation is supplied with SimplaceCDX?
Every order includes a Certificate of Analysis (CoA), sterility certificate, and mycoplasma test results. Full CDM documentation — including component specifications suitable for IND/CTA CMC sections — is available on request. BSE/TSE statements and additional regulatory documents can be provided for GMP customers. Contact our team to discuss your specific documentation requirements before ordering.
What is the difference between SimplaceCDX and SimplaceX?
SimplaceX is serum-free but protein-supplemented — it contains defined protein fractions (e.g. recombinant albumin or transferrin) that are not fully characterised at the component level. SimplaceCDX is fully chemically defined: every component is known, specified, and documented. SimplaceX is the preferred choice for research and process development; SimplaceCDX is required wherever regulatory documentation mandates a fully defined, animal-origin-free medium.
Request a Quote or Sample
48h response · EU & Swiss Supply · Batch reservation available · CDM documentation included
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