Sartorius Stedim Biotech
Sartorius Stedim Biotech now offers good manufacturing practice (GMP) master and working cell banks (MCB/WCB) for mammalian suspension cells. The GMP manufacture of master cell banks is a critical step during the development of biopharmaceutical drugs, where time is always key. The combination of our new manufacturing services and our established characterization service for mammalian cell banks allows clients to work with us as a single-source provider from vial thaw to release of cell banks. Up to 500 cell bank vials are produced during a manufacturing run, followed by full characterization, genetic stability assessment in compliance with EU and U.S. FDA guidelines, and release by the respective qualified person. The cell bank vials produced are then shipped to the client or transferred to a long-term storage facility. With all three services combined—cell line development, cell bank manufacturing, and cell bank characterization—we support clients as a total solutions provider, from DNA to released GMP cell bank within a 10-month timeline.