GMP manufacture of master and working cell banks

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Manufacture 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.

Master cell bank (MCB)

A MCB consisting of 200-300 vials is manufactured from a suitable cell clone to prevent genetic drifts and potential contamination of the original therapeutic-producing cell. The MCB is tested for purity, identity, content, and viability. For animal cells, special emphasis is placed on virus safety testing.

Working cell bank (WCB)

One vial of the MCB is expanded in growth medium and aliquoted as WCB into > 300 vials, which are then cryopreserved under identical conditions as the MCB. Like the MCB, the WCB is tested and characterized with respect to purity, identity, and content/concentration.

Our Services

© Fraunhofer ITEM

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