PromoCell launches PromoExQ MSC Growth Medium XF
The new medium is designed to support long-term expansion of mesenchymal stem cells for cell therapy manufacturing applications
20 Jul 2023
PromoCell's new GMP grade MSC medium
PromoCell, a manufacturer of cell culture products, announces the launch of PromoExQ MSC Growth Medium XF, a serum- and xeno-free cell culture medium designed for good manufacturing practice (GMP)-compliant maintenance and long-term mesenchymal stem cell (MSC) expansion.
PromoExQ MSC Growth Medium XF enables the long-term expansion of a variety of MSC types, including MSCs from the bone marrow, umbilical cord matrix, and adipose tissue, and ensures their consistent growth and maintenance. Analysis of the growth of human MSCs isolated from the bone marrow (BM-hMSCs) showed an average population doubling time of less than 40 hours when cultured in PromoExQ MSC Growth Medium XF.
PromoExQ MSC Growth Medium XF is manufactured under strict quality standards and in compliance with PromoCell's EXCiPACT™ GMP certification scheme, which builds on the ISO 9001:2015 Quality Management System and allows the manufacturing of pharmaceutical excipients. The EXCiPACT GMP certification scheme is aligned with the American National Standard NSF/IPEC/ANSI 363 GMP for pharmaceutical excipients.
PromoCell's PromoExQ MSC Growth Medium XF comes with additional documentation, including Excipient Quality Assessment File (EQAF) comprising relevant basic information (e.g., overview of the manufacturing procedure or the process of quality control), statement of GMP compliance, statement on microbial and viral safety, statement on BSE/TSE status, certificate of origin, declaration of conformity, certificate of analysis, and statement of genetically modified organisms. This documentation allows a comprehensive risk analysis for the user. PromoCell also ensures batch consistency and full traceability of all the materials used to manufacture the medium.
To ensure a smooth transition from assay development and optimization to GMP compliant manufacturing, PromoCell also offers a standard version of the PromoExQ MSC Growth Medium XF, which has the same formulation as the GMP grade product and is produced at the same production site.
PromoExQ MSC Growth Medium XF will be available worldwide in July 2023, with production of large media batches in larger bottle formats or media bags and bulk production of media supplements offered upon request.