Gibco™ CTS™ B-27™ Supplement XenoFree (50X)

Description

CTS B-27 Supplement XenoFree is a cGMP-manufactured, serum-free supplement designed to meet regulatory requirements for cell therapy manufacturing. This supplement supports the growth, proliferation, and differentiation of various cell types derived from pluripotent stem cells (PSCs). Example applications include induction of human neural stem cells (hNSCs), expansion and proliferation 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 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 was specifically designed for use in stem cell research and cell therapy applications by making targeted modifications to the classic serum-free B-27 Supplement. CTS B-27 Supplement XenoFree 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.