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

    Optimization of Antibody Processing: Upstream and Downstream

    Abstract

    Process optimization plays a critical role in therapeutic antibody process development. In this chapter, the time line and achievable goals of process optimization are described. Obtaining high purity and high dosage of the final product using an optimized process with a high titer cell culture are major challenges in large-scale monoclonal antibody production. Approaches for these purposes and several case studies in both upstream and downstream processes are discussed, as well as a cost-efficient and robust process based on implementation of currently advanced technologies.

    About the Authors

    Joe X. Zhou, Scientific Director, Department of Purification Process Development, AMGEN, Inc.
    Dr. Joe X Zhou is 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.

    Tim Tressel, Department of Purification Process Development, AMGEN, Inc.
    Dr. Tim Tressel is the Director of Process Development, heading up a group of 37 scientists and engineers. His responsibility is fully utilize department resources to develop and transfer to manufacturing robust multi-step purification processes suitable for large scale manufacturing of drug substance. Dr. Tressel has been invited as a speaker for many international conferences. He has several research articles and abstracts published in peer- reviewed journals. Dr. Tressel received a Ph.D. in Chemistry from the University of Iowa and completed his post doc training at the City of Hope. Later Tim worked at a start-up biotech company named BioGrowth, Inc. and has been at Amgen Inc. since 1992 in the Purification Process Development Group.

    Tony Hong, Department of Purification Process Development, AMGEN, Inc.
    Mr. Tony Hong is a Scientist at Process Development Department, Amgen, Inc. He graduated from University of California, Davis with B.S. degree in Microbiology in 1991. Tony started his career at Baxter Healthcare Corporation working in GMP manufacturing in 1993. Since then, Tony has worked for Eli Lilly and Company and Allergan, Inc. before joining Amgen in 2003.

    Feng Li, Department of Cellular Sciences and Technology, AMGEN, Inc.
    Dr. Feng Li is a Senior Scientist at Process Development Department, Amgen, Inc. His current responsibilities include CHO cell culture process development, bioreactor scale up, process tech transfer, and cGMP manufacturing tech support. Prior to joining Amgen in 2004, Feng started his career as Process Engineer at Tanox, Inc., where he focused on NS0 cell fed-batch media development and process optimization for therapeutic antibody production. Feng received his Ph.D. degree in Chemical Engineering from Rice University in 2002. He also obtained a M.S. from Tsinghua University and a B.S. from Shanghai Jiaotong University in China. Dr. Li has published various papers in peer-reviewed journals.

    Xiaoming Yang, Department of Cellular Sciences and Technology, AMGEN, Inc.
    Dr. Xiaoming (Jerry) Yang is a Scientific Director in the at Process & Analytical Sciences, Amgen, Inc. He earned his Ph.D. in Biochemical Engineering from Rutgers University. He has eighteen years experience in bioprocess development and biologics GMP. He is a group leader in Cell Science & Technology department and a Process Team Leader for early stage and commercial process development. He is a board member of the Editorial Advisory and Peer-Review Board for BioProcess International and member of SIM and AIchE.

    Brian Lee, Department of Global Process Engineering, AMGEN, Inc.
    Dr. Brian Lee is Principal Scientist at Global Process Engineering Department at Amgen, Inc. He has been involved with biological process development and commercialization for both microbial and cell culture processes during the past 16 years. He has started his scientist career in BioProcess R&D at Merck Research Laboratories and worked for 14 years until he moved to Amgen, Inc. two years ago. He published numerous scientific papers and patents, and participated in presentations at many national and international conferences. He has his M.S. in Bacteriology from University of Wisconsin, Madison and Ph.D. in Biochemistry from Michigan State University with a B.S. in Biology from Seoul National University. He completed a postdoctoral training in Biochemistry at University of California, San Francisco.


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