GMP-grade stem cell media simplifies transition to clinical manufacturing

AMSBIO has introduced GMP-grade StemFit® for Differentiation, a chemically defined, animal component-free medium designed for consistent and efficient differentiation of human induced pluripotent stem (hiPS) and embryonic stem (hES) cells. Now compliant with Good Manufacturing Practices (GMP), this formulation supports seamless progression to clinical applications.

By eliminating animal-derived components, StemFit® for Differentiation minimises immunogenic risks while ensuring lot-to-lot consistency. Manufactured under strict GMP guidelines, it provides a reliable solution for the reproducible expansion and differentiation of stem cell-derived tissues in clinical settings.

Dr Satoshi Okamoto of Yokohama City University Graduate School of Medicine noted:

"Using StemFit® Basic03 for iPSC culture alongside StemFit® for Differentiation, we established a stable, animal-origin-free protocol."

By the end of 2025, all StemFit® formulations, including Basic03 and Basic04 CT, along with key proteins such as bFGF and Activin A, will be available exclusively as GMP-grade versions. This transition enables labs to move from research to clinical manufacturing without the need to retest materials or adjust protocols, reducing both complexity and costs.

To make GMP adoption accessible, AMSBIO has optimised manufacturing to minimise cost differences between research and GMP-grade products

Aisha Amari, a stem cell specialist at AMSBIO, commented:

"With nearly 1,500 citations and growing use in cell and gene therapy, StemFit® has become a trusted solution for researchers and biotech companies worldwide."

Contact AMSBIO for further details about GMP compliant products and services.

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