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Advances in Large-Scale Biopharmaceutical Manufacturing
and Scale-Up Production*, 2nd Edition

    Development of Viral Clearance Strategies for Large-Scale Monoclonal Antibody Production

    Abstract

    Commercial scale antibody production processes require high product throughput operations with an overall robust viral clearance strategy. In this article, an overview of a common antibody process is introduced with specific focus on viral clearance processes. New methods, including disposable device technology, are compared to classical methods. Strategies for designing and testing the viral clearance power delivered by unit operations using a non-GLP facility are discussed.

    About the Authors

    Joe X. Zhou, Scientific Director, Department of Purification Process Development, Amgen, Inc.
    Dr. Joe X. Zhou is a Scientific Director in the Process Development Department, Amgen, Inc. Dr. Zhou’s expertise is in non-cGMP and cGMP protein/antibody therapeutics purification/production. He has experience in all aspects of process research, process optimization, viral clearance, and characterization as well as laboratory set up and project management. Dr. Zhou accomplished six patent applications and five process publications after since Amgen in 2004. Dr. Zhou has received many awards and has been invited as a speaker for many international conferences. He has over 45 full research articles and 12 abstracts published in peer-reviewed journals. Dr. Zhou is also a co-author for six registered US patents before Amgen. Dr. Joe Zhou has his Ph.D. degree in Biopharmaceutical Sciences from Queen’s University of Belfast, M.S. in Enzymology/Biochemistry and B.S. in Microbiology from Liaoning University. He has been a member of American Association of Pharmaceutical Scientists for over 10 years and currently is a member of American Chemistry Society.

    Houman Dehghani, Ph.D, Senior Scientist, Global Cellular and Analytical Resources, Amgen, Inc.
    Dr. Dehghani is a Principal Scientist at Amgen, Inc. His area of expertise is molecular virology and viral pathogenesis. Following his post-doctoral training at the National Institute of Allergy and Infectious Diseases, he joined Amgen, Inc. in 2003 as a member of the Biosafety Development Laboratory. Currently he heads the Biosafety Development Laboratory, which is involved with viral clearance assessment studies in both cGMP and development settings. He is the member of American Association of Pharmaceutical Scientists and Parenteral Drug Association.


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