Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade.
Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
Author(s): Wayne R. Gombotz, Steven J. Shire (auth.), Steven J. Shire, Wayne Gombotz, Karoline Bechtold-Peters, James Andya (eds.)
Series: Biotechnology: Pharmaceutical Aspects XI
Edition: 1
Publisher: Springer-Verlag New York
Year: 2010
Language: English
Pages: 354
Tags: Neurosciences; Pharmacology/Toxicology
Front Matter....Pages i-xiv
Front Matter....Pages 8-8
Introduction....Pages 1-5
CDR Repair: A Novel Approach to Antibody Humanization....Pages 9-28
Nanobodies, Single-Domain Antigen-Binding Fragments of Camelid Heavy-Chain Antibodies....Pages 29-48
Front Matter....Pages 50-50
GPEx ® A Flexible Method for the Rapid Generation of Stable, High Expressing, Antibody Producing Mammalian Cell Lines....Pages 51-62
Advancing Our Cell Culture Platform: Incorporating Lessons Learned and New Technologies....Pages 63-72
Front Matter....Pages 74-74
Addressing Changes Associated with Technology Transfer: A Case Study....Pages 75-85
Concepts for Disposables in Biopharmaceutical Manufacture....Pages 87-99
Front Matter....Pages 102-102
Formulation and Delivery Issues for Monoclonal Antibody Therapeutics....Pages 103-129
Challenges in the Development of High Protein Concentration Formulations....Pages 131-147
Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization....Pages 149-175
Front Matter....Pages 178-178
Characterizing High Affinity Antigen/Antibody Complexes by Kinetic and Equilibrium Based Methods....Pages 179-192
Analytical Characterization of Monoclonal Antibodies: Linking Structure to Function....Pages 193-205
Analysis of Irreversible Aggregation, Reversible Self-association and Fragmentation of Monoclonal Antibodies by Analytical Ultracentrifugation....Pages 207-227
Biophysical Signatures of Monoclonal Antibodies....Pages 229-246
Front Matter....Pages 248-248
Impact of Fc Glycosylation on Monoclonal Antibody Effector Functions and Degradation by Proteases....Pages 249-269
Immunogenicity Assessment of Antibody Therapeutics....Pages 271-291
Front Matter....Pages 294-294
Production of Monoclonal Antibodies in E. coli ....Pages 295-308
Recent Advancements in the Use of Antibody Drug Conjugates for Cancer Therapy....Pages 309-322
Antibody Radiolabeling....Pages 323-344
Back Matter....Pages 345-351
