Biosimilars of Monoclonal Antibodies

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

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.