Use of bovine serum in the manufacture of human biological medicinal products - Scientific guideline

This document outlines the general principles that should be applied to the control of the quality and safety of bovine serum used during the manufacture of human biological medicinal products. It applies to vaccines and biotechnological products. It also covers dossier requirements for marketing authorisation applications/variations.

Keywords: Bovine serum, adventitious agents, bovine viral diarrhoea virus (BVDV), viral inactivation