PromoExQ MSC Growth Medium XF

Serum- and xeno-free cell culture medium designed for the expansion of human MSCs in a GMP regulated environment to serve as therapeutics.

Key benefits:

• GMP grade*: Produced in compliance with EXCiPACT™ GMP certification scheme for pharmaceutical excipients
• Regulatory support: The relevant supporting documentation is included in the product
• Batch consistency: We proactively inform you about changes in raw material specifications, which may impact the regulatory status
• Streamlined transition: We provide both a research grade and a GMP grade version of our PromoExQ MSC Growth Medium XF. The release specifications of the functional performance assays of the research grade medium are identical to the GMP grade cell culture medium. Therefore, we help you minimize the effort when switching to GMP related applications
• Flexible: Contact us for customized media options and upscaling in media bags

Components:

• PromoExQ MSC Basal Medium XF
• SupplementMix PromoExQ MSC XF
• Regulatory support documentation package

Our PromoExQ MSC Growth Medium XF is a serum- and xeno-free medium manufactured under the highest quality standards. Our medium was optimized for the in vitro expansion of human MSCs in a GMP regulated environment, providing consistent growth and maintenance of a variety of multipotent mesenchymal stem cells (MSCs), including MSCs from the bone marrow, umbilical cord matrix (Wharton’s jelly), and adipose tissue.
The PromoExQ MSC Growth Medium XF is produced in accordance with the EXCiPACT™ GMP certification scheme, which builds on our existing ISO 9001:2015 quality management system. The EXCiPACT™ GMP certification standard supports the manufacturing of pharmaceutical excipients and is fully aligned with the American National Standard for Good Manufacturing Practices according to NSF/IPEC/ANSI 363.
When planning to move from research into a GMP compliant process (e.g., manufacturing cell-based therapies or cell-derived vaccines), it is necessary to assess the safety and the risks of your cell culture. For this risk assessment, you will need documentation and certificates that ensure the safety of the process and submit these documents to the competent regulatory authority. These documents prove the product’s safety and provide information about the quality and origin of the raw material, as well as the manufacturing conditions and packaging of the product.
Our PromoExQ MSC Growth Medium XF comes with relevant supporting documentation free of charge, sparing you the time and effort to collect all the documents you need for your risk assessment.

The document package includes:

• Excipient quality assessment file (EQAF)
• Statement of GMP compliance
• Statement on microbial and viral safety (MVS)
• Statement on BSE/TSE status
• Certificate of origin (CoO)
• Declaration of conformity
• Statement of genetically modified organisms (GMO)
• Certificate of analysis (CoA)

Furthermore, we proactively inform you about changes in raw material specifications, which may impact the regulatory status and ensure consistent lot-to-lot performance. With each batch of medium, you receive the relevant supporting documentation you need.
In addition to the GMP grade PromoExQ MSC Growth Medium XF, we also provide a research grade version to minimize the effort when switching to a GMP compliant process. The release specifications of the functional performance assays of the research grade medium are identical to the GMP grade cell culture medium. This allows you to establish your assays using the standard medium and then switch to the GMP grade product, that is produced at the same site.
As we own our entire manufacturing process, we can create customized products (e.g., media bags) to meet your needs during the entire pipeline — from assay development to manufacturing.

Note: Our PromoExQ MSC Growth Medium XF does not contain attachment or spreading factors. Therefore, fibronectin or vitronectin coating of culture vessels is required.

Intended use: The regulated products are intended for research use or manufacturing. They are not intended for direct administration to humans or animals. For safety precautions, please refer to the appropriate MSDS.

*”GMP grade” is a branding term used by PromoCell to denote reagents that are manufactured at the PromoCell manufacturing facility in Heidelberg, Germany, under strictly controlled processes to meet stringent product specifications and customer requirements. Reagents manufactured at PromoCell are produced according to EXCiPACT^TM GMP standards, a quality management system that builds on our ISO 9001:2015 certification and the ANSI certification. Risk assessment procedures are carried out at the customer site.