Millipore Technical Publications |
 | DS- SDS1704ENEU | |
MicroSafe Biosafety Solutions Laboratory, Europe - Bovine Virus Testing | ||
| Lit No: | SDS1704ENEU | |
| Year: | 2006 | |
| Material of ruminant origin (bovine serum) may be an essential ingredient in the culture media of cells used in the production of many medicinal biological products. Bovine Viral Diarrhea Virus (BVDV) is a highly prevalent infection in cattle and its presence in bovine serum cannot be completely avoided.1 The potential presence of extraneous agents in bovine serum represents a risk to the safety of the biological medicinal product. The testing and removal of BVDV is essential to control the quality and safety of bovine serum used during the manufacture of human biological medicinal products including vaccines and biotech products.1 1 Committee for Proprietary Medicinal Products, Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products. CPMP/BWP/1793/02, (European Agency for the Evaluation of Medicinal Products, London, Current). Click the PDF above for the full document. | |
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