GMP Drug Substance: Cell Banking

7 July 2021

The GMP Drug Substance process begins with cell banking. Master Cell Bank (MCB) and Working Cell Bank (WCB) manufacturing must be worked out according to Live Biotherapeutic Product Guidelines, and Biose Industrie is fully equipped to do so.

  • Where does Biose Industrie house the cell banking equipment?

Biose Industrie has a specific zone in its plant, which is accessed via an additional airlock and gowning suite. Inside this zone is all the necessary equipment to create MCBs/WCBs for any type of bacteria. This zone also serves as the area where specific inocula are created for all our GMP fermentations. This requires adaptation to the different strains, with high-level pharmaceutical sterile conditions.

  • Where are the Biose Industrie MCB storage facilities?

The company has two different MCB storage facilities in two different buildings on its site. Should this not prove suitable for a client, Biose Industrie offers a third off-site storage solution.