Current Trends in Monoclonal Antibody Development and Manufacturing

Description

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. 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