Emerging Virus and TSE Issues for Bovine-Derived Raw Materials Used in the Manufacture of Biological Products

by Merribeth J. Morin, PhD
Volume 2, Issue 1 (January/February 2003)

The use of animal products, such as bovine serum, in the manufacture of biologics is a common practive. The United States' Code of Federal Regulations, part nine (9CFR), dictates mandatory testing for viruses. In the last few years, we have learned that certain viruses undetected in industry standard tests, like the 9CFR assay, can cause significant contamination of bovine products. Last year in Europe, new guidelines from the Committee for Veterinary Medicinal Products (CVMP), and draft guidelines from the Committee for Proprietary Medicinal Products (CPMP), were published to address testing requirements for bovine serum. The use of these European Guidelines for bovine serum testing broadens the ability to detect viral contamination...

Citation:
Morin MJ. Emerging Virus and TSE Issues for Bovine-Derived Raw Materials Used in the Manufacture of Biological Products. BioProcess J, 2003; 2(1): 58-61.