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Descrizione
Gibco CTS Essential 8 Medium is a fully-defined, feeder-free medium designed for the growth and expansion of hPSCs for clinical applications and formulated with components not directly derived from animals. The formulation of CTS Essential 8 Medium is based on Essential 8™ Medium, which was originally developed by Guokai Chen et al. in the laboratory of James Thomson (published as 'E8'). CTS Essential 8 Medium provides similar performance to Essential 8 Medium, supporting the transition from the bench to the clinic.
CTS Essential 8 Medium:
- Reduces risks with a fully defined formulation
- Simplifies the transition from bench to clinic with similar performance and the same 8-component formulation as RUO Essential 8 Medium, but with components not directly derived from animals
- Facilitates customer regulatory filings with cGMP manufacturing, traceability of raw materials, and available documentation, including certificates of origin, drug master files, and regulatory support
Reduces risks from animal-origin material
CTS Essential 8 Medium contains no animal- or human-derived components at the primary component level. It is a fully defined medium for pluripotent stem cell culture.
Simplifies transition from bench to clinic
Like RUO Essential 8 Medium, CTS Essential 8 Medium contains only the eight essential components needed for stem cell culture, but with components not directly derived from animals. Pluripotent stem cells (PSCs) cultured in CTS Essential 8 Medium have been shown to maintain PSC marker expression after long-term culture and to generate cells of the three germ lineages.
Combined with cGMP manufacturing, this simple, fully defined formulation improves consistency compared to other media that contain over 20 highly variable ingredients. The close similarity between Essential 8 Medium and CTS Essential 8 Medium supports the transition from one medium to the other.
Facilitates regulatory filings
Gibco CTS products are manufactured at a site that uses methods and controls that conform with cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing site is ISO 13485-certified. Specific intended-use statements, full documentation traceability, and convenient access to our Drug Master File (DMF) are available for CTS Essential 8 Medium.
CTS Essential 8 Medium is commercialized in partnership with Cellular Dynamics International.
Specifica
Specifica
| Tipo di cellula | Embryonic Stem Cells (ESCs), Induced Pluripotent Stem Cells (iPSCs) |
| Classificazione | Xeno-free |
| Forma | Liquid |
| Product Type | Cell Culture Medium |
| Sterilità | Sterile-filtered |
| Da utilizzare con (applicazione) | Cell and Gene Therapy Research, Development, and Manufacturing |
| Qualità di produzione | ISO 13485, MDSAP, FDA-registered, 21 CFR 820 |
| Quantità | 500 mL |
| Shipping Condition | CTS Essential 8 Medium: Ambient, CTS Essential 8 Supplement: Dry Ice |
| Formato | Bottle |
| Vedi altri risultati |
For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.
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