European Regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products.

This article gives an overview of the principles of the European Regulatory guidance on virus safety and virus validation for products derived from mammalian cell lines (recombinant DNA products and monoclonal antibodies) and from human blood. It provides an insight of the current views of the European authorities on the virus safety aspects of these different kinds of products. For biotechnology (rDNA and mAb) products, the article elaborates on the experience gained within the centralised procedure and illustrates this by means of a survey of the virus validation studies of all biotechnology medicinal products authorised in the European Union from the beginning of 1995 to mid-2003. Trends in model viruses used in the virus validation studies and virus removal/inactivation steps for these products are identified in the survey. For plasma derivatives, this overview illustrates how EU regulatory guidance on the virus safety of plasma-derived medicinal products is kept under review and links to the topics discussed during the PDA-EMEA Virus Safety Forum.