CTS B-27 Supplement XenoFree is based on the classic serum-free B-27 supplement and designed to help meet regulatory requirements forRead more
Have Questions?
Catalog number A5047501
Price (USD)
302.00
Each
Add to cart
Price (USD)
302.00
Each
Add to cart
CTS B-27 Supplement XenoFree is based on the classic serum-free B-27 supplement and designed to help 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). Example applications include induction of human neural stem cells (hNSCs), expansion of hNSCs, differentiation of hNSCs, and maintenance of mature differentiated neurons in culture.
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 is formulated with only AOF recombinant components and human-derived 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.
Specifications
ClassificationSerum-free, Xeno-free
Concentration50X
Culture TypeCells derived from Pluripotent Stem Cells (PSCs)
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.
How do I request the traceability documentation for CTS B-27 Supplement Xeno-Free?
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).
What accompanying documentation is available for CTS B-27 Supplement Xeno-Free?
Traceability documentation including FDA Drug Master Files and/or Regulatory Support Files, certificates of analysis, and certificates of origin are available upon request.