1. Lubiniecki AS, Wiebe ME, and Builder SE (1990) Process validation for cell culture derived pharmaceutical proteins. In Lubiniecki AS (ed.) Large Scale Mammalian Cell Culture Technology, Marcel Dekker Inc, NY, pp. 515?541.
2. Office of Biologics Research and Review (1993) ?Points to consider in the manufacture and testing of monoclonal antibody products for human use?, Food and Drug Administration, Md, 1994 and Office of Biologics Research and Review, ?Points to consider in the characterization of cell lines used to produce biologicals?, Food and Drug Administration, Md.
3. Commission of the European Communities, (1991) Note for Guidance: Validation of virus removal and inactivation procedures. Brussels. Belgium.
4. Dinowitz M, Lie YS, Low M-AL, Lazar R, Fautz C, Potts B, Sernatinger J, and Anderson K, (1992) Recent studies on retrovirus-like particles in Chinese hamster ovary cells. Develop. Biol. Standard. 76: 201?207.
5. Lubiniecki AS, Dinowitz M, Nelson E, Wiebe M, May L, Ogez J and Builder S (1989) Endogenous retroviruses of continuous cell substrates. Develop. Biol. Standard., 70: 187?191.