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Beskrivelse
Gibco CTS StemPro-34 SF XenoFree Medium er et yderst effektivt medium designet til vækst og udvikling af humane hæmatopoietiske celler i kultur, herunder hæmatopoietiske stamceller (HSC'er) og forløberceller fra knoglemarv, nyfødt navlestrengsblod og perifert blod.
Key benefits for cell and gene therapy applications
- Serum-free and xeno-free—formulated without serum or non-human derived components to comply with global regulatory standards for ancillary materials in cell therapy manufacturing; formulated with L-glutamine and without phenol red
- Supports cell differentiation—facilitates differentiation of induced pluripotent stem cells (iPSCs) to HSCs and further differentiation into immune cells (NK cells, T-cells, B-cells, macrophages, etc.)
Regulatory compliance and quality assurance
- cGMP manufactured—produced in accordance with 21 CFR part 820 and ISO 9001 and ISO 13485 standards to help ensure the highest quality and safety
- USP <1043> compliant—designed to meet USP <1043> standards for ancillary materials used in cell, gene, and tissue-engineered products
Seamless integration with closed system workflows
CTS StemPro-34 SF XenoFree Medium is available in both 500-mL bottle and 2-liter bioprocessing container (BPC) formats, supporting processes through cell therapy development and manufacturing. The BPC chamber is constructed from Aegis 5-14 film and includes sterile, weldable DEHP-free PVC tubing with Luer lock and C-Flex tubing with MPC quick connector. This helps provide versatile connection options, helping ensure maximum sterility and efficiency in your manufacturing process. The 2-L kit format includes both supplement and basal components in BPCs for closed system workflows.
Comprehensive documentation for regulatory support
To facilitate your regulatory submissions, CTS StemPro-34 SF XenoFree Medium comes with an extensive documentation package, including certificates of analysis (COA), access to drug master files (DMFs), and/or regulatory support files (RSFs), and certificates of origin (COO) upon request.
Choose CTS StemPro-34 SF XenoFree Medium for a robust, regulatory-compliant solution that supports the critical processes in cell and gene therapy manufacturing, helping ensure the highest standards of quality and safety.
Tekniske data
Tekniske data
| Klassifikation | Xeno-free, Serum-free, cGMP |
| Form | Liquid |
| Produkttype | Bottle Kit |
| Serum niveau | Serum-free |
| Sterilitet | Sterile-filtered |
| Steriliseringsmetode | Sterile-filtered |
| Med tilsætningsstoffer | Glutamine |
| Uden tilsætningsstoffer | No Phenol Red |
| Mængde | 500 mL |
| Kultur Type | Stem Cell (Human, iPS - Induced Pluripotent Stem, Embryonic), Suspension Cell Culture, 3D Cell Culture |
Til forskningsbrug eller fremstilling af celle-, gen- eller vævsbaserede produkter. FORSIGTIG: Ikke beregnet til direkte administration i mennesker eller dyr.
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