Current Trends in Monoclonal Antibody Development and Manufacturing

1. Introduction
Wayne R. Gombotz, Steven J. Shire

2. CDR Repair: A Novel Approach to Antibody Humanization
Mark S. Dennis

3. Nanobodies, Single-Domain Antigen-Binding Fragments of Camelid Heavy-Chain Antibodies
Gholamreza Hassanzadeh Ghassabeh, Serge Muyldermans, Dirk Saerens

4. GPEx® A Flexible Method for the Rapid Generation of Stable, High Expressing, Antibody Producing Mammalian Cell Lines
Gregory T. Bleck

5. Advancing Our Cell Culture Platform: Incorporating Lessons Learned and New Technologies
Carole Heath

6. Addressing Changes Associated with Technology Transfer: A Case Study
Michele M. Myers, Camille Keating, Joann Bannon, Donald S. Neblock, Peter W. Wojciechowski

7. Concepts for Disposables in Biopharmaceutical Manufacture
Joachim K. Walter, Uwe Gottschalk

8. Formulation and Delivery Issues for Monoclonal Antibody Therapeutics
Ann L. Daugherty, Randall J. Mrsny

9. Challenges in the Development of High Protein Concentration Formulations
Steven J. Shire, Zahra Shahrokh, Jun Liu

10. Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization
Karoline Bechtold-Peters

11. Characterizing High Affinity Antigen/Antibody Complexes by Kinetic and Equilibrium Based Methods
Andrew W. Drake, David G. Myszka, Scott L. Klakamp

12. Analytical Characterization of Monoclonal Antibodies: Linking Structure to Function
Reed J. Harris, Edward T. Chin, Frank Macchi, Rodney G. Keck, Bao-Jen Shyong, Victor T. Ling, Armando J. Cordoba, Melinda Marian, Don Sinclair, John E. Battersby, Andy J. S. Jones

13. Analysis of Irreversible Aggregation, Reversible Self-association and Fragmentation of Monoclonal Antibodies by Analytical Ultracentrifugation
James D. Andya, Jun Liu, Steven J. Shire

14. Biophysical Signatures of Monoclonal Antibodies
N. Harn, T. Spitznagel, M. Perkins, C. Allan, S. Shire, C. R. Middaugh

15. Impact of Fc Glycosylation on Monoclonal Antibody Effector Functions and Degradation by Proteases
T. Shantha Raju

16. Immunogenicity Assessment of Antibody Therapeutics
P. Stas, Y. Gansemans, I. Lasters

17. Production of Monoclonal Antibodies in E. coli

Dorothea E. Reilly, Daniel G. Yansura

18. Recent Advancements in the Use of Antibody Drug Conjugates for Cancer Therapy
Peter D. Senter

19. Antibody Radiolabeling
Corinne Bensimon, Russell Redshaw

Avainsanat: Biomedicine, Neurosciences, Pharmacology/Toxicology