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Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
* Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs
* Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible
* Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information
* Examines new technologies and strategies for improving biosimilar mAbs
List of contents
Notes on Contributors xxv
Preface xli
1 The History of Therapeutic Monoclonal Antibodies 1
Regis Sodoyer
1.1 Summary 1
1.2 Introduction 1
1.3 New Markets for Old Antibodies, Old Markets for New Antibodies 2
1.4 Antibody Engineering: A New Approach to the Treatment of Disease 5
1.5 Fully Human Antibodies, What Else? 8
1.6 Antibody Design 17
1.7 Antibody Production 30
1.8 Recombinant Antibodies: No Limits... 37
Acknowledgments 37
References 37
2 Structure, Classification, and Naming of Therapeutic Monoclonal Antibodies 63
Zhinan Xia
2.1 Summary 63
2.2 Introduction 64
2.3 Antibody Structure 65
2.4 Classification of Antibodies 71
2.5 IgG Subtype 73
2.6 Nomenclature of Therapeutic mAbs 73
2.7 List of Therapeutic mAbs on Market or in Review in the European Union and the United States 82
References 82
3 Mechanism of Action for Therapeutic Antibodies 85
Yu Zhou and James D. Marks
3.1 Introduction 85
3.2 Blockade of Ligand-Receptor Interaction 86
3.3 Target Depletion via ADCC and CDC 94
3.4 Engaging Cytotoxic T Cell Through the Use of Bispecific Abs 95
3.5 Receptor Downregulation by Enhanced Internalization and Degradation 96
3.6 Targeted Drug Delivery 96
3.7 Summary 98
References 98
4 Therapeutic Monoclonal Antibodies and Their Targets 113
Jose A. Figueroa, Camilo Pena, Leonardo Mirandola, Adair Reidy, J. Drew Payne, Nattamol Hosiriluck, Natallia Suvorava, Rakhshanda Layeequr Rahman, Adrienne R. Whitlow, Rashmi Verma, Everardo Cobos, and Maurizio Chiriva-Internati
4.1 Summary 113
4.2 Introduction 114
4.3 Monoclonal Antibody Therapies for Infectious Diseases 117
4.4 Monoclonal Antibody Therapies for Autoimmune Diseases 120
4.5 Therapeutic Monoclonal Antibodies Against Neoplastic Diseases 127
4.6 Conclusion 138
References 140
5 Antibody Posttranslational Modifications 155
Roy Jefferis
5.1 Summary 155
5.2 Introduction 155
5.3 Overview of Co- and Posttranslational Modifications 157
5.4 Glycosylation 162
5.5 Glycation 172
5.6 IgG-Fab Glycosylation 179
5.7 The Influence of Expression Platform on CTM/PTMs and Unintended Physicochemical Changes 181
5.8 Human Antibody Isotypes Other than IgG 182
5.9 Conclusion 182
References 183
6 The Pharmacology, Pharmacokinetics, and Pharmacodynamics of Antibodies 201
Ningning Xu, Meimei Liu, and Margaret Liu
6.1 Summary 201
6.2 Introduction 201
6.3 Pharmacology of Anticancer MAbs 202
6.4 Antibody Pharmacokinetics 204
6.5 Pharmacodynamics 208
6.6 Conclusions 211
References 211
7 Monoclonal Antibodies: Applications in Clinical Oncology 217
Jeanene ("Gigi") Robison
7.1 Summary 217
7.2 Introduction 217
7.3 Ado-trastuzumab Emtansine (Anti-HER2 Antibody Conjugated with Emtansine, Kadcyla(r)) 218
7.4 Alemtuzumab (Campath(r), Campath-1H) 220
7.5 Bevacizumab (Avastin) 221
7.6 Brentuximab Vedotin (Anti-CD30 Antibody, Adcetris(r)) 225
7.7 Cetuximab (Anti-EGFR Antibody, Erbitux(r)) 227
7.8 Denosumab (Anti-RANKL Antibody, Xgeva(TM); Prolia(TM)) 230
7.9 Eculizumab (Anti-C5 Antibody, Soliris(r)) 233
7.10 Ibritumomab Tiuxetan (Anti-CD20 Antibody, Zevalin(r)) 235
7.11 Ipilimumab (Anti-CTLA-4 Antibody, Yervoy(r)) 237
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About the author
Cheng Liu, PhD, is founder and CEO of Eureka Therapeutics, a biotech company dedicated to monoclonal antibody drug discovery and development for unmet medical needs. He is an expert on therapeutic antibody and engineering, and a frequent speaker at pharmaceutical conferences. He holds multiple issued US and international patents in the field of therapeutic antibody discovery and engineering and has authored many scientific publications in the field of cancer immunotherapy. Dr. Liu was awarded Special Congressional Recognition for his contributions to improving human health in 2007.
K. John Morrow, Jr., PhD, is President and CEO of Newport Biotechnology Consultants, and has worked in academia and in the private sector. He has published a total of over 280 peer-reviewed articles, reports in biotechnology trade papers, chapters in books, and full length books. He serves as a consultant for Meridian Bioscience, Inc., in Cincinnati, OH and for Point A Consulting in Louisville, KY.
Summary
Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
