GMP-compliant cell culture medium optimises API manufacture

AMSBIO has unveiled an upgraded GMP-compliant version of its animal-origin-free, chemically defined StemFit™ iPSC expansion medium. StemFit™ Basic04 CT is engineered to enhance the growth and pluripotency of induced pluripotent stem cells (iPSC) while meeting the stringent Good Manufacturing Practice (GMP) standards for Active Pharmaceutical Ingredients (API).

With its superior iPSC performance, StemFit™ Basic04 CT facilitates expansion and sustains long-term genetic stability, optimising single-cell passaging for large-scale stem cell production. This medium is meticulously manufactured and quality-controlled in strict accordance with GMP guidelines within a certified ISO 13485 facility.

Each bottle of StemFit™ Basic04 CT is accompanied by a certificate of analysis and all necessary documentation, ensuring a seamless transition to clinical applications. Aisha Amari, Business Development specialist at AMSBIO, emphasised the significance of iPSCs in revolutionising cellular medicines and highlighted the pivotal role of GMP-compliant StemFit™ Basic04 CT in iPSC manufacturing for cell therapy.

Amari stated: "Using StemFit™, we hope researchers can further advance translational research, drug discovery and development and help bring high-quality iPSC based- therapies from bench to bedside."

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