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.