PromoCell, a leading manufacturer of cell culture products, announced the launch of PromoExQ MSC Growth Medium XF, a serum- and xeno-free cell culture medium designed for GMP compliant maintenance and long-term expansion of mesenchymal stem cells (MSCs) for cell therapy manufacturing applications.
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 the new solution.
Irma Börcsök, managing director of PromoCell, said, "We are proud to offer our customers a product that is essential for the success of their cell therapy manufacturing applications. With our expertise and the new product, we can advance research and development in this field and contribute to improving healthcare."
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 certification scheme is aligned with the American National Standard NSF/IPEC/ANSI 363 GMP for pharmaceutical excipients.
The new solution 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.
"With our new PromoExQ MSC Growth Medium XF, it was our highest priority to provide all required documents fast and easily together with the GMP grade medium. We know how critical it is for the regulatory approval of our customers’ new therapies to perform all risk assessments in the early stages. By providing all documentation, we help our clients save time and money," Börcsök said.
To ensure a smooth transition from assay development and optimisation 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.
