ABSTRACT
This chapter is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin (i.e., mammalian, avian, insect) and outlines data that should be submitted in the marketing application/registration package. It covers the products derived from cell cultures initiated from characterized cell banks and products derived from in vitro cell culture, such as interferons, monoclonal antibodies, and recombinant DNA-derived products including recombinant subunit vaccines. The chapter includes products derived from hybridoma cells grown in vivo as ascites. The risk of viral contamination is a feature common to all biotechnology products derived from cell lines. Such contamination could have serious clinical consequences and can arise from the contamination of the source cell lines themselves (cell substrates) or from adventitious introduction of virus during production.
