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 therefore ensuring product consistency while managing risk by eliminating contamination and genetic instability.
Our clinical stem cell services:
- GMP iPSC production service
- GMP MSC production service
- Ready to use GMP Mesenchymal Stem Cells
- StemEdit clinical gene editing service
Specifically, iPSCs are straightforward to genetically manipulate, and they open the path for innovative therapeutics such as gene correction for the therapeutic rescue of genetic diseases, the addition of genes at precise genome sites, or 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 but not limited to donor eligibility, CoAs, batch records, traceability documentation, and quality technical agreements for your GMP Master Cell Bank or Cell Therapy product.