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Session 9: Manufacturing

Session 9: Manufacturing not available. [09.15–09.45] ‘cDNA to antibody candidate selection to a 3– 5 g/L therapeutic antibody production process in six months’ Gregory T. Bleck Catalent Pharma Solutions, Middleton, Wisconsin, USA A consistent procedure to allow antibody candidate screening on the path to a high expressing therapeutic antibody cell line is critical for quickly moving antibodies from discovery to clinical trials. The GPEx method allows different antibody variants or subclasses (mg to gram quantities) to be produced for characterization and screening 10-12 weeks after start of development from a pool of clonal cell lines. Selection of the therapeutic candidate occurs after analysis of the various CHO produced antibodies, and clonal cell lines are developed for the lead molecule. The resulting clonal cell lines have specific productivities ranging between 30 and 100 picograms/cell/day and final antibody titers of 3–5 g/L in the selected culture process. Our experience making CHO cell lines producing over 150 different antibodies will be summarized and case studies of antibody cell line development will be discussed. [09.45–10.05] ‘Manufacturing human antibodies for preclinical research and market, today and tomorrow’ Florian M. Wurm and Maria De Jesus Swiss Federal Institute of Technology, Lausanne, Switzerland Specific antibodies or antibody-fusion proteins http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Human Antibodies IOS Press

Session 9: Manufacturing

Human Antibodies , Volume 19 (2) – Jan 1, 2010
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Publisher
IOS Press
Copyright
Copyright © 2010 by IOS Press, Inc
ISSN
1093-2607
eISSN
1875-869X
DOI
10.3233/HAB-2010-0225
Publisher site
See Article on Publisher Site

Abstract

not available. [09.15–09.45] ‘cDNA to antibody candidate selection to a 3– 5 g/L therapeutic antibody production process in six months’ Gregory T. Bleck Catalent Pharma Solutions, Middleton, Wisconsin, USA A consistent procedure to allow antibody candidate screening on the path to a high expressing therapeutic antibody cell line is critical for quickly moving antibodies from discovery to clinical trials. The GPEx method allows different antibody variants or subclasses (mg to gram quantities) to be produced for characterization and screening 10-12 weeks after start of development from a pool of clonal cell lines. Selection of the therapeutic candidate occurs after analysis of the various CHO produced antibodies, and clonal cell lines are developed for the lead molecule. The resulting clonal cell lines have specific productivities ranging between 30 and 100 picograms/cell/day and final antibody titers of 3–5 g/L in the selected culture process. Our experience making CHO cell lines producing over 150 different antibodies will be summarized and case studies of antibody cell line development will be discussed. [09.45–10.05] ‘Manufacturing human antibodies for preclinical research and market, today and tomorrow’ Florian M. Wurm and Maria De Jesus Swiss Federal Institute of Technology, Lausanne, Switzerland Specific antibodies or antibody-fusion proteins

Journal

Human Antibodies – IOS Press

Published: Jan 1, 2010

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