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Avoiding viral contamination in biotechnological and pharmaceutical processes

Nature Biotechnology volume 16, pages 1077–1079 (1998)Cite this article

Almost all biological substances of value are produced from materials of animal or human origin, such as cultured cells, organs, medium components, or blood. Thus, the danger exists that manufactured biopharmaceutical products bear a risk of viral contamination. This has been shown by numerous epidemiological investigations, e.g., for classical serum hepatitis (hepatitis B virus, HBV) and for other infections by blood contamination. With the recent appearance of disease-causing human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections related to transfusions, the safety of pharmaceutical and biotechnological drugs with respect to viral contamination is now more important than ever.

Targeted selection of the starting material, as well as screening procedures such as investigation for viral markers (e.g., antibodies), are not sufficient to guarantee the safety of the products and to exclude the possibility of viral transfer. There is a need for effective elimination/inactivation methods integrated into the production process or designed as additional barriers. Inactivation of viruses is achieved by the destruction of their lipid or protein covers, making them unrecognizable to the target cell, or by destroying the viral nucleic acid, and therefore the biological activity necessary for replication. Acute concern for virus transmission from biological products derived from natural sources has led to the development of various viral clearance methods.

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Acknowledgements

We are grateful to Guenter Huebner and Christian Goelker for providing data of the Trasylol process and helpful discussions. We also thank Brian Schwegler and Isabell Guenther for proofreading.

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Authors and Affiliations

  1. a research fellow Bayer AG, D-51368, Leverkusen, Germany

    Hans-Jürgen Henzler

  2. group leader of the biotechnological processes group, Bayer AG, D-51368, Leverkusen, Germany

    Klaus Kaiser

Authors
  1. Hans-Jürgen Henzler
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  2. Klaus Kaiser
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Henzler, HJ., Kaiser, K. Avoiding viral contamination in biotechnological and pharmaceutical processes . Nat Biotechnol 16, 1077–1079 (1998). https://doi.org/10.1038/3538

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