| Biopharmaceutical products such as recombinant proteins, monoclonal antibodies, vaccines, and blood- and plasma-related products, must fulfil complex requirements regarding quality and safety. Many of these products have often had contact with bovine material, either as a constituent of the product itself, or by indirect contact during production. Since bovine spongiform encephalopathy (BSE) was identified in the UK in 1986, the use of bovine material in medicinal products has prompted action by national and international regulatory authorities to assure the continued safety of these products.This article provides a brief overview of the subject of prion safety, the actions of international regulatory authorities, and the consequences for the manufacturing industry of medicinal products. |
