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Risk Mitigation in Preventing Adventitious Agent Contamination of Mammalian Cell Cultures

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New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins

Part of the book series: Advances in Biochemical Engineering/Biotechnology ((ABE,volume 165))

Abstract

Industrial-scale mammalian cell culture processes have been contaminated by viruses during the culturing phase. Although the historical frequency of such events has been quite low, the impact of contamination can be significant for the manufacturing company and for the supply of the product to patients. This chapter discusses sources of adventitious agent contamination risk in a cell culture process, provides a semiquantitative assessment of such risks, and describes potential process barriers that can be used to reduce contamination risk. High-temperature, short-time (HTST) heat treatment is recommended as the process barrier of choice, when compatible with the process. A case study assessing the compatibility of HTST heat treatment with a cell culture medium is presented, and lessons learned are shared from our experiences over many years of developing and implementing virus barriers in mammalian cell culture processes.

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Acknowledgments

We acknowledge many individuals too numerous to specifically name who, over the course of many years since the initial decision to develop and implement additional virus barriers, have contributed significant time and effort to ensuring success. It has truly taken a village.

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Authors and Affiliations

  1. Genentech, Inc. (A Member of the Roche Group), San Francisco, CA, USA

    Masaru Shiratori & Robert Kiss

Authors
  1. Masaru Shiratori
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  2. Robert Kiss
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Corresponding author

Correspondence to Masaru Shiratori .

Editor information

Editors and Affiliations

  1. Sutro Biopharma Inc., San Francisco, CA, USA

    Bob Kiss

  2. Lonza, Basel, Switzerland

    Uwe Gottschalk

  3. Solothurn Manufacturing Facility, Biogen International GmbH, Luterbach, Switzerland

    Michael Pohlscheidt

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Shiratori, M., Kiss, R. (2017). Risk Mitigation in Preventing Adventitious Agent Contamination of Mammalian Cell Cultures. In: Kiss, B., Gottschalk, U., Pohlscheidt, M. (eds) New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins. Advances in Biochemical Engineering/Biotechnology, vol 165. Springer, Cham. https://doi.org/10.1007/10_2017_38

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