PowerStem MSC1, Serum-free medium for human mesenchymal stem cells (hMSC), GMP grade

PowerStem MSC1 GMP grade is a fully defined, xeno-free and serum-free cell culture system specifically developed for the clinical-scale expansion of human mesenchymal stem cells (hMSC).

Designed in compliance with Good Manufacturing Practice (GMP EU Annex 1) requirements, this advanced medium supports robust proliferation while maintaining the functional integrity and multipotency of MSCs.

Building on the proven performance of the research-use-only (RUO) formulation, PowerStem MSC1 enables reduced variability and improved consistency, while significantly minimizing the risk of contamination associated with serum-containing systems.

Key Features

• GMP EU Annex 1-compliant production
  Manufactured under stringent GMP EU Annex 1 conditions, ensuring full traceability, documentation, and batch-to-batch consistency required for clinical and commercial manufacturing.
• Xeno-free & serum-free formulation
  Eliminates animal-derived components, reducing immunogenicity risks and supporting regulatory acceptance for human therapeutic applications.
• Optimized for MSC expansion
  Promotes rapid proliferation while preserving MSC identity, including expression of key markers (CD90, CD105, CD73) and absence of hematopoietic markers (CD34, CD45).
• Maintains multipotency
  Supports long-term culture while preserving the ability of MSCs to differentiate into multiple lineages such as osteogenic, chondrogenic, and adipogenic cells.

Advantages for Clinical and Industrial Applications

• Regulatory readiness
  The GMP-grade formulation facilitates seamless integration into cell therapy manufacturing workflows, supporting regulatory compliance.
• Reproducibility & process standardization
  Defined, serum-free composition ensures consistent performance across batches, a critical requirement for scalable manufacturing and quality control.
• Enhanced safety profile
  Absence of serum and xenogeneic components minimizes the risk of pathogen transmission and immunological complications.
• Scalable manufacturing
  Suitable for large-scale bioprocessing, enabling efficient expansion of MSCs for applications in regenerative medicine, immunotherapy, and tissue engineering.
• Process compatibility
  Designed for use in controlled environments and compatible with closed and automated systems, supporting modern cell therapy production platforms.

Applications

• Clinical-grade expansion of human mesenchymal stem cells (hMSC)
• Cell and gene therapy manufacturing
• Regenerative medicine and tissue engineering
• Advanced therapy medicinal products (ATMPs)