This is a preview of subscription content, log in via an institution to check access.
References
Nicklas, W., Kraft, V., Meyer, B. 1993. Contamination of transplantable tumors, cell-lines and monoclonal antibodies with rodent viruses. Lab. Anim. Sci. 43: 296–300.
Minor, P. 1993. Virological aspects of the quality control of human monoclonal antibodies, International Association of the Biological Standardization, Developments in biological standardization, S. Karger AG, Basel :233–236.
Trijzelaar, B. 1993. Regulatory affairs and biotechnology in Europe. III. Introduction into good regulatory practice: Validation of virus removal and inactivation. Biotherapy 6: 93–102.
Frommer, W. et al. 1993. Safe biotechnology (5). Recommendations for safe work with animal and human cell cultures concerning potential human pathogens. Appl. Microbiol. Biotechnol. 39: 141–147.
EEC Regulatory Document—Note for guidance—Validation of virus removal and inactivation procedures. 1991. Biologicals 19: 247–251.
Webster, R.G. and Granoff, A. 1994. Encyclopedia of virology: Vol. 1–3. Academic Press, London.
Tateishi, J. et al. 1993 Removal of causative agent of Creutzfeldt-Jakob-disease (CJD) through membrane filtration method. Membrane 18: 357–362.
Prusiner, S.B. 1982. Novel proteinaceous infectious particles cause scrapie. Science 216: 136–144.
Roitt, I.M., Brostoff, J., Male, D.K., 1991 Lehrbuch der Immunologie. Georg Thieme Verlag, Stuttgart.
DiLeo, A.J. and Allegrezza, A.E. 1991 Validatable virus removal from protein solutions. Nature 351: 420–421.
Tsurumi, T., Osawa, N., Hitaka, H., and Hirasaki, T. 1990. Structure of cuprammonium regenerated cellulose hollow fiber (BMM hollow fiber) for virus removal. Polym. J. 22: 751–758.
White, E.M., Grun, J.B., Sun, C.-S., and Sito, A.F. 1991. Process validation for virus removal and inactivation. Reprinted from Biopharm.
Hamamoto, Y. et al. 1989. A novel method for removal of human immunodeficiency virus: Filtration with porous polymeric membranes. Vox Sang 56: 230–236.
Tsuboi, T. et al. 1992. Combination of virus removal and inactivation for the process validation of bio-drugs. Murakami.H., Shirahata, S., Tachibana, H., Animal cell technology: Basic and applied aspects, Kluwer Academic Publishers, Dordrecht :289–294.
Burnouf-Radosevich, M., Appourchaux, P., Huart, J.J., and Burnouf, T. 1994. a new specific virus elimination method applied to high-purity factor IX and factor XI concentrates. Vox Sang. 67: 132–138.
Manabe, S. et al. 1991. Elimination of microorganisms from cell culture medium using regenerated cellulose hollow fiber (BMM). Sasaki, R. & Ikura, K., Animal Cell Culture and Production of Biologicals, Kluwer Academic Publishers, Dordrecht: 87–94.
Tomokiyo, K. et al. 1991. Studies on virus elimination and inactivation effects of highly purified factor VIII concentrates. Jpn. Clin. Rep. 25: 1–8.
Sekiguchi, S. et al. 1989. Possibility of hepatitis B virus removal from human plasma using regenerated cellulose hollow fiber (BMM). Membrane 14: 77–83.
Yasua, T. et al. 1991. The particle size of hepatitis C virus estimated by filtration through microporous regenerated cellulose fibre. J. Gen. Virolog. 72: 2021–2024.
EC note for guidance: Validation of virus removal and inactivation procedures. 1991. Pharmacol. Toxicol. 69: 144–148.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Maerz, H., Hahn, S., Maassen, A. et al. Improved removal of viruslike particles from purified monoclonal antibody IgM preparation via virus filtration. Nat Biotechnol 14, 651–652 (1996). https://doi.org/10.1038/nbt0596-651
Issue Date:
DOI: https://doi.org/10.1038/nbt0596-651
- Springer Nature America, Inc.
This article is cited by
-
Avoiding viral contamination in biotechnological and pharmaceutical processes
Nature Biotechnology (1998)