Advancing induced pluripotent stem cell (iPSC) therapy research to clinical applications requires researchers to carefully select materials, as the quality of starting materials has a significant impact on the properties of the final stem cell therapy product.
Thermo Fisher Scientific has developed Gibco Cell Therapy Systems (CTS) products throughout the pluripotent stem cell therapy workflow, aiming to help facilitate the transition from discovery to commercial manufacturing. The company provides high-quality ancillary materials manufactured under Good Manufacturing Practices (GMP), helping ensure commercial scale production. These materials are extensively qualified, traceable, and accompanied by regulatory documentation.
- Scalable manufacturing under GMP conditions—CTS iPSC media and reagents are manufactured in conformity with GMP for medical devices, 21 CFR Part 820, and follow USP<1043> and Ph Eur 5.2.12, and the manufacturing sites are FDA-registered and ISO 13485- and/or ISO 9001-certified. The investment in rigorous product manufacturing helps ensure the consistency, reliability, and high quality of iPSC therapy reagents in combination with the ability to scale up and accommodate changing needs.
- Quality control testing and regulatory documentation—CTS iPSC media and reagents help minimize the risk of contamination and variability in research with extensive safety testing, including sterility, endotoxin, and mycoplasma. Full traceability for raw materials is also available, including Drug Master Files, Regulatory Support Files, and Certificates of Origin.
- Proven use from research to clinic—An extensive selection of serum-free, xeno-free, or animal origin-free formulations with cell therapy specific intended use statements and complementary research use reagents. Our CTS products have been used in over 200 clinical trials as well as in commercially approved cell therapies including FDA-approved CAR-T therapies and the first FDA-approved therapeutic cancer vaccine.