AMSBIO has launched GMP grade StemFit® for Differentiation – a chemically defined and animal component-free formulation that enables unmatched differentiation of human Induced Pluripotent Stem (hiPS) and Embryonic Stem (hES) cells. This medium now complies with Good Manufacturing Practices, as required for downstream clinical applications.
The unique chemically defined composition of StemFit® for Differentiation minimizes lot-to-lot variation, enabling highly consistent cell differentiation. The animal-origin free composition minimizes the risk of immunogenic contamination. Manufactured to strict GMP guidelines, the new gold standard version of StemFit® for Differentiation offers highly reproducible expansion and differentiation of human pluripotent stem cell-derived cells and tissues in clinical manufacturing applications.
Dr. Satoshi Okamoto from the Yokohama City University Graduate School of Medicine said “Using StemFit® Basic03 for iPSC cell culture with StemFit® for Differentiation for differentiation, we were able to adopt animal-origin free reagents, which made our culture protocol very stable.”
By the end of 2025, all StemFit® formulations including Basic03, Basic04 CT, and key proteins including bFGF and Activin A, will be available exclusively as GMP-grade formulations. Transitioning the range to GMP grade ensures that every lab using StemFit® can seamlessly move from research to clinical applications without needing to retest materials or change protocols and so reducing complexity and cost.
To keep GMP grade formulations adoption accessible, manufacturing processes have been optimized to minimize the cost difference between research and GMP-grade versions. This ensures that labs can upgrade to GMP without significant financial burden.
Aisha Amari, a stem cell specialist at AMSBIO commented “StemFit® has earned the trust of researchers and biotech companies worldwide, with nearly 1,500 citations and growing adoption in cell and gene therapy”.
To learn more about GMP compliant products and services from AMSBIO please visit https://www.amsbio.com/gmp/gmp-products-services/. For further information about StemFit® for Differentiation please visit https://www.amsbio.com/stemfit-for-differentiation/ or contact AMSBIO on +31-72-8080244 / +44-1235-828200 / +1-617-945-5033 / info@amsbio.com.
