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GMP Drug Substance: Cell Banking

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..Read more

GMP Drug Substance Part 1: Scope

The first step in process development for live biotherapeutic product manufacturing is to identify the microbe that will be used in the drug product and assess the conditions it needs to grow. There are several parameters that must be taken into account, as different bacteria will require different approaches. Aerobic..Read more