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.
Irma Börcsök, PhD, 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 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.
“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,” Dr. Börcsök said.
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 via the PromoCell webstore. Production of large media batches in larger bottle formats or media bags and bulk production of media supplements will be offered upon request.
For more information about the PromoExQ MSC Growth Medium XF, visit PromoCell's website.
About PromoCell
PromoCell GmbH, headquartered in Heidelberg, Germany, is a leading manufacturer of cell culture products with over 30 years of expertise. The company offers a broad range of high-quality human primary cells, stem cells, media, and reagents for life science research and cell therapy manufacturing applications.
All PromoCell products meet the highest ethical and legal standards. By complying with European biomedical conventions, we respect human rights and donor privacy. We are committed to quality – in our products and customer services.
Each year over 1,000 peer-reviewed publications feature PromoCell products. We operate in 38 countries around the world, helping scientists with all of their research needs.
Learn more about PromoCell on our website, or connect with us on LinkedIn, Facebook, YouTube, or Twitter.