• EMA Draft Guidance Adds Testing Requirements for Manufacturers of Bovine Serum

    The European medicines Agency (EMA) has released a new draft guideline for manufacturers who use bovine serum when producing biologics for human consumption, adding additional testing requirements to screen for bovine viral diarrhea virus (BVDV). The 1 October draft guideline, Use of bovine serum in the manufacture of human biological medicinal products , specifically revises two sections of a 2003 guideline on the same topic: Sections 7.3.3 and 7.3.4, both of which per...