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...

GMP Drug Substance Development is an important part of product development for clients of Biose Industrie. Our team members are expert problem solvers who ensure the manufacturing consistently outputs a live biotherapeutic product to certain quality specifications, while documenting all steps in the process. Several stages are involved: Selecting a process appropriate to the strain(s)...