Therapeutic Monoclonal Antibodies: From Bench to Clinic

Foreword ix

Preface xi

Contributors xiii

Part I Antibody Basics

1. Therapeutic Monoclonal Antibodies: Past, Present, and Future 3
William R. Strohl

2. Antibody Molecular Structure 51
Robyn L. Stanfield and Ian A. Wilson

3. Glycosylation of Therapeutic IgGs 67
Yusuke Mimura, Roy Jefferis, Yuka Mimura-Kimura, Jodie Abrahams, and Pauline M. Rudd

4. Antibody Databases and Tools: The IMGTw Experience 91
Marie-Paule Lefranc

Part II Antibody Sources

5. Human Antibodies from Transgenic Mice 117
Nils Lonberg

6. Rabbit Hybridoma 151
Weimin Zhu and Guo-Liang Yu

7. Human Antibody Repertoire Libraries 169
David Lowe and Tristan J. Vaughan

Part III In Vitro Display Technology

8. Antibody Phage Display 191
Michael Hust, Holger Thie, Thomas Schirrmann, and Stefan Dübel

9. Yeast Surface Display 213
Jennifer L. Lahti and Jennifer R. Cochran

10. Ribosomal Display 239
George Thom

11. Bacterial Display of Antibodies 255
Thomas J. Van Blarcom and Barrett R. Harvey

12. Antibody Selection from Immunoglobulin Libraries Expressed in Mammalian Cells 283
Ernest S. Smith and Maurice Zauderer

Part IV Antibody Engineering

13. Antibody Engineering: Humanization, Affinity Maturation, and Selection Techniques 311
Juan C. Almagro and William R. Strohl

14. Modulation of Serum Protein Homeostasis and Transcytosis by the Neonatal Fc Receptor 335
William F. Dall’Acqua and Herren Wu

15. Engineering the Antibody Fc Region for Optimal Effector Function 349
Greg A. Lazar and John R. Desjarlais

Part V Physiology And In Vivo Biology

16. Antibody-Complement Interaction 373
Kileen L. Mershon and Sherie L. Morrison

17. Bacteria Immunoglobulin-Binding Proteins: Biology and Practical Applications 385
Leslie Cope and Tessie McNeely

18. Immunogenicity Screening Using in Silico Methods: Correlation between T-Cell Epitope Content and Clinical Immunogenicity of Monoclonal Antibodies 417
Si-Han Hai, Julie A. McMurry, Paul M. Knopf, William Martin, and Anne S. De Groot

19. Monoclonal Antibody Pharmacokinetics and Pharmacodynamics 439
Christopher R. Gibson, Punam Sandhu, and William D. Hanley

20. Biodistribution and Imaging 461
Tove Olafsen and Anna M. Wu

21. Antibodies and the Blood-Brain Barrier 483
Angela R. Jones and Eric V. Shusta

Part VI Antibody Characterization

22. Determination of Equilibrium Dissociation Constants 505
Robin E. Ernst, Katrina N. High, Tom R. Glass, and Qinjian Zhao

23. Molecular and Functional Characterization of Monoclonal Antibodies 525
Qinjian Zhao, Terrance A. Stadheim, Lorenzo Chen, and Michael W. Washabaugh

24. Characterization of Heterogeneity in Monoclonal Antibody Products 541
Yang Wang, Michael W. Washabaugh, and Qinjian Zhao

Part VII Antibody Expression

25. Antibody Expression in Mammalian Cells 557
Fubao Wang, Lorenzo Chen, Neal Connors, and Henryk Mach

26. Production of Antibodies in Pichia pastoris 573
Juergen H. Nett

27. Production of Antibody Fab0 Fragments in E. coli 589
David P. Humphreys and Leigh Bowering

28. Production of Human Therapeutic Monoclonal Antibodies in Chicken Eggs 623
Lei Zhu and Robert J. Etches

29. Production of Antibodies in Plants 651
Kevin M. Cox, Jeffrey T. Regan, Jason D. Sterling, Vincent P. M. Wingate, and Lynn F. Dickey

Part VIII Therapeutic Antibodies

30. The Formulation and Delivery of Monoclonal Antibodies 675
Vikas K. Sharma, Hung-Wei Chih, Randall J. Mrsny, and Ann L. Daugherty

31. Therapeutic Antibodies in Clinical Use and Leading Clinical Candidates 711
Ningyan Zhang, Brent R. Williams, Ping Lu, Zhiqiang An, and Chen-Ni Chin

32. Follow-On Protein Products: What, Where, When, How? 763
Brent R. Williams and William R. Strohl

33. Monomeric Fc Fusion Molecules 779
Jennifer A. Dumont, Susan C. Low, Robert T. Peters, and Alan J. Bitonti

34. Radioimmunotherapy: Current Status and Future Directions 797
Neeta Pandit-Taskar and Chaitanya R. Divgi

35. Antibody-Drug Conjugate Therapy 821
Stephen C. Alley, Dennis Benjamin, and Che-Leung Law

Abbreviations 857

Index 865