Therapeutic Monoclonal Antibodies

ZHIQIANG AN, PHD, is the Chief Scientific Officer of Epitomics, Inc., in Burlingame, California. Previously, he was Director of Biologics Research at Merck Research Laboratories, West Point, Pennsylvania. Dr. An started his biotech/pharmaceutical career at Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts. He received a doctor of philosophy degree from the University of Kentucky, Lexington, followed by postdoctoral training at the University of Wisconsin–Madison.

• Foreword ixPreface xiContributors xiiiPart I Antibody Basics1. Therapeutic Monoclonal Antibodies: Past, Present, and Future 3William R. Strohl2. Antibody Molecular Structure 51Robyn L. Stanfield and Ian A. Wilson3. Glycosylation of Therapeutic IgGs 67Yusuke Mimura, Roy Jefferis, Yuka Mimura-Kimura, Jodie Abrahams, and Pauline M. Rudd4. Antibody Databases and Tools: The IMGTw Experience 91Marie-Paule LefrancPart II Antibody Sources5. Human Antibodies from Transgenic Mice 117Nils Lonberg6. Rabbit Hybridoma 151Weimin Zhu and Guo-Liang Yu7. Human Antibody Repertoire Libraries 169David Lowe and Tristan J. VaughanPart III In Vitro Display Technology8. Antibody Phage Display 191Michael Hust, Holger Thie, Thomas Schirrmann, and Stefan Dübel9. Yeast Surface Display 213Jennifer L. Lahti and Jennifer R. Cochran10. Ribosomal Display 239George Thom11. Bacterial Display of Antibodies 255Thomas J. Van Blarcom and Barrett R. Harvey12. Antibody Selection from Immunoglobulin Libraries Expressed in Mammalian Cells 283Ernest S. Smith and Maurice ZaudererPart IV Antibody Engineering13. Antibody Engineering: Humanization, Affinity Maturation, and Selection Techniques 311Juan C. Almagro and William R. Strohl14. Modulation of Serum Protein Homeostasis and Transcytosis by the Neonatal Fc Receptor 335William F. Dall’Acqua and Herren Wu15. Engineering the Antibody Fc Region for Optimal Effector Function 349Greg A. Lazar and John R. DesjarlaisPart V Physiology And In Vivo Biology16. Antibody-Complement Interaction 373Kileen L. Mershon and Sherie L. Morrison17. Bacteria Immunoglobulin-Binding Proteins: Biology and Practical Applications 385Leslie Cope and Tessie McNeely18. Immunogenicity Screening Using in Silico Methods: Correlation between T-Cell Epitope Content and Clinical Immunogenicity of Monoclonal Antibodies 417Si-Han Hai, Julie A. McMurry, Paul M. Knopf, William Martin, and Anne S. De Groot19. Monoclonal Antibody Pharmacokinetics and Pharmacodynamics 439Christopher R. Gibson, Punam Sandhu, and William D. Hanley20. Biodistribution and Imaging 461Tove Olafsen and Anna M. Wu21. Antibodies and the Blood-Brain Barrier 483Angela R. Jones and Eric V. ShustaPart VI Antibody Characterization22. Determination of Equilibrium Dissociation Constants 505Robin E. Ernst, Katrina N. High, Tom R. Glass, and Qinjian Zhao23. Molecular and Functional Characterization of Monoclonal Antibodies 525Qinjian Zhao, Terrance A. Stadheim, Lorenzo Chen, and Michael W. Washabaugh24. Characterization of Heterogeneity in Monoclonal Antibody Products 541Yang Wang, Michael W. Washabaugh, and Qinjian ZhaoPart VII Antibody Expression25. Antibody Expression in Mammalian Cells 557Fubao Wang, Lorenzo Chen, Neal Connors, and Henryk Mach26. Production of Antibodies in Pichia pastoris 573Juergen H. Nett27. Production of Antibody Fab0 Fragments in E. coli 589David P. Humphreys and Leigh Bowering28. Production of Human Therapeutic Monoclonal Antibodies in Chicken Eggs 623Lei Zhu and Robert J. Etches29. Production of Antibodies in Plants 651Kevin M. Cox, Jeffrey T. Regan, Jason D. Sterling, Vincent P. M. Wingate, and Lynn F. DickeyPart VIII Therapeutic Antibodies30. The Formulation and Delivery of Monoclonal Antibodies 675Vikas K. Sharma, Hung-Wei Chih, Randall J. Mrsny, and Ann L. Daugherty31. Therapeutic Antibodies in Clinical Use and Leading Clinical Candidates 711Ningyan Zhang, Brent R. Williams, Ping Lu, Zhiqiang An, and Chen-Ni Chin32. Follow-On Protein Products: What, Where, When, How? 763Brent R. Williams and William R. Strohl33. Monomeric Fc Fusion Molecules 779Jennifer A. Dumont, Susan C. Low, Robert T. Peters, and Alan J. Bitonti34. Radioimmunotherapy: Current Status and Future Directions 797Neeta Pandit-Taskar and Chaitanya R. Divgi35. Antibody-Drug Conjugate Therapy 821Stephen C. Alley, Dennis Benjamin, and Che-Leung LawAbbreviations 857Index 865