Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

GMP manufacturing of master and working cell banks

GMP manufacture of master and working cell banks
© Fraunhofer ITEM

Manufacturing of cell banks represents the first GMP element in the life cycle and production chain of a medicinal product. It is a prerequisite for consistent production of a biological API. Since repeated subcultures or multiple generations of organisms can result in unforeseeable changes in properties and integrity, production of every biological drug substance is based on a master cell bank (MCB) and a working cell bank (WCB) prepared with low numbers of generation doublings. A two-tier cell bank system consisting of a MCB and WCB guarantees consistent raw material/cellular substrate supply over the life cycle of a biopharmaceutical drug product and beyond.

An additional aspect is the storage of cell banks. This should take place in a secure, controlled, and monitored cell bank system at ultra-deep temperatures, i.e. in the gas phase above liquid nitrogen.

Our Services

  • ICH Q5D-compliant GMP manufacture of master and working cell banks (MCB and WCB) of prokaryotic and eukaryotic organisms, e. g., bacteria, yeasts, fungi, and mammalian cell lines
  • Quantity of MCB or WCB vials: up to 300
  • Volume of MCB or WCB: 1 ml to 5 ml per cryovial
  • Specially equipped production facilities, i.e., class-D and class-C clean rooms for cell banking
  • 25  years of in-house technical and regulatory expertise
  • GMP-compliant storage of MCB and WCB at ultra-low temperatures (< -150 °C) in the gas phase of liquid nitrogen
  • For testing and characterization, Fraunhofer ITEM has already established contractual relationships with several testing laboratories

Contact

Claudius Seitz

Contact Press / Media

Dr.-Ing. Claudius Seitz

Management Team Pharamceutical Biotechnology & Manager of the Working Group on Microbial Cultivation

Phone +49 531 6181-6347