Developing cellular therapies requires strict adherence to manufacturing and regulatory standards that are different for each national regulatory agency. REPROCELL can help you through all stages of your regenerative medicine project.
Cell-based therapies have significant potential to provide patient relief in a broad range of disease areas, from cancer to degenerative disorders. Many of these projects start with iPSCs (induced pluripotent stem cells) or with MSCs (mesenchymal stem cells). Master cell banks (MCBs) can be effectively generated from these stem cells, ensuring product consistency while managing risk by eliminating contamination and genetic instability.
Specifically, iPSCs are straightforward to manipulate genetically, and the modified iPSCs open the path for innovative therapeutics. Some examples include gene correction for the therapeutic rescue of genetic diseases, the addition of genes at precise genome sites, and the creation of hypoimmune lines that can overcome HLA mismatches.
Whether your project starts with iPSCs or MSCs as the source for your stem cell-based therapeutic project, or if you are interested in clinical gene editing, REPROCELL can assist you!
REPROCELL is a global company that serves customers all around the world. Our worldwide presence ensures that our client's cell therapy projects are compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA. We will provide the necessary quality and regulatory documents including donor eligibility, CoAs, batch records, traceability documentation, and quality technical agreements for your GMP Master Cell Bank or Cell Therapy product.
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