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GMP Compliant Cell Culture Medium Streamlines API Manufacture

Cells under a microscope.
Credit: AMSBIO.
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AMSBIO has launched an enhanced GMP-compliant version of its animal-origin-free, chemically defined StemFit™ iPSC expansion medium.


StemFit™ Basic04 CT is designed to improve the growth and pluripotency of induced pluripotent stem cells (iPSC) and meet the Good Manufacturing Practice (GMP) standards for Active Pharmaceutical Ingredients (API).


Offering superior iPSC performance, expansion, and maintenance of long-term genetic stability - StemFit™ Basic04 CT is optimized for single cell passaging, making it ideal for use in large-scale production of stem cells.


The manufacturing and quality control of this exciting new product are managed in strict accordance with GMP standards in a certified ISO 13485 facility. All bottles of StemFit™ Basic04 CT come provided with a certificate of analysis and any documentation required for a seamless transition to clinical applications.


Aisha Amari, Business Development specialist at AMSBIO said “iPSCs are increasingly being used for developing and discovering cellular medicines that have the potential to change the way doctors treat intractable diseases. She added “The GMP-compliant StemFit™ Basic04 CT is key in the manufacturing of iPSCs for use in cell therapy. 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.”