Viral Evaluation of Animal Cell Lines Used in Biotechnology

Animal cell culture is being increasingly used for production of therapeutic reagents such as monoclonal antibodies, recombinant proteins, viral vaccines and replication incompetent viral vectors for gene therapy. Material derived from a variety of biological processes has been associated in the past with incidents involving the transmission of infectious agents, principally viruses (1 ). Thus, virological evaluation of animal cell substrates for use in the manufacture of biologicals is essential to ensure the safety of products for pharmaceutical use.