Experimental approaches to guarantee minimal risk of potential virus in purified monoclonal antibodies

Author:

Berthold W.,Walter J.,Werz W.

Publisher

Springer Science and Business Media LLC

Subject

Cell Biology,Clinical Biochemistry,Biomedical Engineering,Bioengineering,Biotechnology

Reference7 articles.

1. Alain R, Nadon F, Séquin C, Payment P and Trudel M (1987) Rapid virus submit visualization by direct sedimentation of samples on electron microscope grids. J Virol Meth 16: 209–216.

2. Andersson KP, Low M-AL, Lie YS, Lazar R, Keller G and Dinowitz M. Defective Endogenous Retroviruslike Particles of Chinese Hamster Ovary Cells. In: Production of Biologicals from Animal Cells in Culture, Spier RE, Griffiths JB and Meignier B (eds) ESACT, The 10th Meeting, Avignon, France.

3. DiLeo AJ and Allegrezza AE Jr (1991) Validentable virus removal from protein solutions.

4. DiLeo AJ, Allegrezza AE Jr and Builder SE (1992) High resolution removal of virus from protein solutions using a membrane of unique structure. Bio/Technology 10: 182–188. Guidelines-Guidelines on the production and quality control of medicinal products derived by recombinant DNA-technology (EC-Commission. Notes to applicants for marketing authorization, DG III/860/86-EN) Tibtech (December 1987) 5: 61–68.-Guidelines on the production and quality control of monoclonal antibodies of murine origin intended for use in man (EC-Commission. Notes to applicants for marketing authorizations) Tibtech (January 1988) 6: 65–68.-Points to consider in the characterization of cell lines used to produce Biologicals 1987 FDA. Office of Biologics Research and Review, 8800 Rockville Pike, Bethesda MD, 20892 USA.-Points to consider for monoclonals.-EG Guidelines: Notes for guidance, Validation of virus removal and inactivation procedures, EC DG III/8115/89-EN proposed date for coming into operation 15.08.91.

5. Löwer J. Virological aspects of quality control of Biologicals Quantitative Considerations (in press).

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