Description
Quantity: 10 mL
Unit Size: Each
CTS qualityGibco 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 SheetReduced risk from animal-origin materials and human-derived componentsCTS B-27 Supplement XenoFree minus Insulin 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 Insulin 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 Insulin 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.
