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Beskrivning
Gibco CTS StemPro-34 SF XenoFree Medium is a highly effective medium designed for the growth and development of human hematopoietic cells in culture, including hematopoietic stem cells (HSCs) and progenitor cells sourced from bone marrow, neonatal cord blood, and peripheral blood.
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.
Specifikationer
Specifikationer
| Klassificering | Xeno-free, Serum-free, cGMP |
| Form | Liquid |
| Produkttyp | Bottle Kit |
| Serumnivå | Serum-free |
| Sterilitet | Sterile-filtered |
| Steriliseringsmetod | Sterile-filtered |
| Med tillsatser | Glutamine |
| Utan tillsatser | No Phenol Red |
| Kvantitet | 500 mL |
| Typ av kultur | Stem Cell (Human, iPS - Induced Pluripotent Stem, Embryonic), Suspension Cell Culture, 3D Cell Culture |
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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