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 is will available worldwide. 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 visit: https://promocell.com/product/promoexq-msc-growth-medium-xf/
Digital issue: Please click here for more information