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Gibco™ CTS™ B-27™ Supplement, XenoFree, minus vitamin A (50X)
Description
Gibco CTS B-27 Supplement, XenoFree, minus vitamin A, is a cGMP-manufactured, serum-free supplement designed to meet regulatory requirements for cell therapy manufacturing. It supports the growth and differentiation of a variety of cell types derived from pluripotent stem cells (PSCs). The absence of vitamin A makes this formulation ideal for the cultivation and expansion of neural progenitor and stem cells without inducing differentiation until desired.
CTS quality
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 sites are ISO 13485– and ISO 9001–certified.
Accompanied by documentation to support your regulatory filing
- Access to our Drug Master File (DMF) or Regulatory Support File (RSF)
- Traceability documentation—Certificate of Origin, Certificate of Analysis, and Safety Data Sheet
Reduced risk from animal-origin materials and human-derived components
CTS B-27 Supplement, XenoFree, minus vitamin A, is formulated with human-derived components and AOF recombinant components. To help reduce viral clearance risks, the use of human-derived components has been minimized and human-derived components are limited to materials that help meet regulatory standards for donor qualification, viral testing, and viral inactivation.
CTS B-27 Supplement, XenoFree, minus vitamin A, was specifically designed for use in cell therapy applications by making targeted modifications to the classic serum-free B-27 Supplement. CTS B-27 Supplement, XenoFree, minus vitamin A, supports the robust growth, expansion, and differentiation of stem cells, making it a valuable addition to any cell therapy protocol where cGMP standards are required.
Specifications
Specifications
| Content And Storage | Store at -5°C to -20°C and protect from light. |
| Classification | Serum-free, Xeno-free |
| Concentration | 50X |
| Culture Type | Cells derived from Pluripotent Stem Cells (PSCs) |
| Form | Liquid |
| Product Type | Cell Culture Supplement |
| Sterility | Sterile-filtered |
| For Use With (Application) | Cell and Gene Therapy Research, Development, and Manufacturing |
| Manufacturing Quality | ISO 13485, MDSAP, FDA-registered, 21 CFR 820 |
| Quantity | 10 mL |
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Frequently Asked Questions (FAQs)
The Gibco Cell Therapy Systems (CTS) portfolio of cell and gene therapy products are GMP manufactured, safety tested, and backed by regulatory documentation to support your transition from discovery through clinical and commercial manufacturing. Through our CTS solutions, we are committed to helping customers streamline therapeutic development, minimize risk, and ease the burden on their quality systems. Learn more here.
Yes, examples include CTS Neurobasal Medium (Cat. No. A13712), CTS Neurobasal-A Medium (Cat. No. A13710), and CTS KnockOut DMEM/F12 (Cat. No. A13708).
For instructions on how to request traceability documentation, please visit the Cell Therapy Systems Support webpage (https://www.thermofisher.com/us/en/home/clinical/cell-gene-therapy/cell-therapy/cell-therapy-systems/cell-therapy-systems-support.html).
Traceability documentation including FDA Drug Master Files and/or Regulatory Support Files, certificates of analysis, and certificates of origin are available upon request.
CTS B-27 Supplement Xeno-Free is available in three versions:
- CTS B-27 Supplement Xeno-Free (Cat. No. A5047501)
- CTS B-27 Supplement Xeno-Free minus Vitamin A (50X) (Cat. No. A5047601)
- CTS B-27 Supplement Xeno-Free minus Insulin (50X) (Cat. No. A5047701)
For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.