Regulatory Compliance

• 9CFR 113.53 Requirements for ingredients of animal origin used for production of biologics.
• 9CFR 113.46 Detection of cytopathogenic and/or hemadsorbing agents
• 9CFR 113.47 Detection of extraneous viruses by the fluorescent antibody technique
• EMEA CPMP Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products. CPMP/BWP/1793/02
• European Pharmacopoeia Draft Monograph 'Bovine Serum'(2003) studies.