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

    Implementation of Membrane Technology in Antibody Large-Scale Purification

    Abstract

    The large-scale production of recombinant human monoclonal antibodies demands economical purification processes with high throughputs. In this chapter we briefly describe a common antibody process and evaluate the Q membrane adsorber for process-scale antibody production as an alternative to a Q-packed-bed column in a flow-through mode. The scientific concepts underlining Q membrane technology and its application are reviewed. The disadvantages and advantages of using Q membrane chromatography as a purification unit in large-scale production are discussed, including problems initially seen with the Q membrane scale-down model but solved with the invention of a new scale-down model. The new Q-membrane unit operation has a process capacity greater than 3000g/m2 or 10.7kg/L with a LRV over 5 for 4 model viruses. In this chapter, a cost analysis illustrates that Q membrane chromatography is a viable alternative to Q column chromatography as a polishing step in a flow-through mode for processscale antibody production. The implementation of membrane technology with other ligand-chemistry in antibody purification is also discussed.

    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 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.


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