Biosimilars of monoclonal antibodies : a practical guide to manufacturing and preclinical and clinical development /: a practical guide to manufacturing and preclinical and clinical development. (2015)

• Record Type: Book
• Further Information: Note: K. John Morrow ; edited by Cheng Liu.
• Authors: Morrow, John, 1938-
• Editors: Liu, Cheng
• 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®) 218 7.4 Alemtuzumab (Campath®, Campath-1H) 220 7.5 Bevacizumab (Avastin) 221 7.6 Brentuximab Vedotin (Anti-CD30 Antibody, Adcetris®) 225 7.7 Cetuximab (Anti-EGFR Antibody, Erbitux®) 227 7.8 Denosumab (Anti-RANKL Antibody, Xgeva™; Prolia™) 230 7.9 Eculizumab (Anti-C5 Antibody, Soliris®) 233 7.10 Ibritumomab Tiuxetan (Anti-CD20 Antibody, Zevalin®) 235 7.11 Ipilimumab (Anti-CTLA-4 Antibody, Yervoy®) 237 7.12 Obinutuzumab (Gazyva®) 238 7.13 Ofatumumab (Anti-CD20 Antibody, Arzerra®) 240 7.14 Panitumumab (Anti-EGFR Antibody, Vectibix™) 242 7.15 Pembrolizumab (Keytruda®) 244 7.16 Pertuzumab (Perjeta®) 246 7.17 Ramucirumab (Cyramza®) 248 7.18 Rituximab (Anti-CD20 Antibody, Rituxan) 250 7.19 Tositumomab and Iodine I-131 Tositumomab (Anti-CD20 Antibody, Bexxar®) 256 7.20 Trastuzumab (Anti-HER2 Antibody, Herceptin®) 258 References 262 8 Development of Biosimilar Rituximab and Clinical Experience 269 ; Reena Nair 8.1 Summary 269 8.2 Introduction 270 8.3 Reditux Development Overview 271 8.4 Preclinical and Toxicology Studies 276 8.5 Clinical Evaluation 276 8.6 Conclusions 280 References 280 9 Monoclonal Antibodies for Infectious Diseases 283 ; Steven J. Projan 9.1 Summary 283 9.2 Into the Future: Prophylaxis and Precision Medicine 283 9.3 Immune Therapy: A Noble Undertaking that Went to the Dogs 284 9.4 What’s Taking So Long? 285 9.5 Staphylococcus aureus: Still Public Enemy Number One? 285 9.6 Pseudomonas aeruginosa: The Bacterial Cockroach 286 9.7 Immune Evasion and Degree of Difficulty 287 9.8 Clostridium difficile: You Can’t Win for Losing 287 9.9 If Two Is Enough, Is Six Too Many? mAb Combos 288 9.10 Prophylaxis or Therapy? When You Come to a Fork in the Road, Take It 288 9.11 Influenza and Plan “B” 288 9.12 Safety: Human Enough for You? 288 9.13 Another Precinct Is Heard from Immunomodulatory Agents for the Treatment of Chronic Infections 289 9.14 Are We There Yet? Easy to Use, Fast Turnaround, Point-of-Care Diagnostics 289 9.15 Yeah but Aren’t These (Biologic) Drugs Going to Be Expensive? 290 References 290 10 Monoclonal Antibodies for Musculoskeletal, CNS, and Other Diseases 293 ; Junming Yie and Tao Wu 10.1 Summary 293 10.2 Natalizumab (Tysabri®) 294 10.3 Eculizumab (Soliris®) 297 10.4 Ranibizumab (Lucentis®) 300 10.5 Denosumab (Prolia® and Xgeva®) 304 10.6 Antibody Therapies for Solid Organ Transplantation (Muromonab-CD3 (Orthoclone OKT3®), Basiliximab (Simulect®), and Daclizumab (Zenapax®)) 307 10.7 Conclusion 314 References 318 11 Manufacture of Recombinant Therapeutic Proteins Using Chinese Hamster Ovary Cells in Large-Scale Bioreactors: History, Methods, and Perspectives 327 ; Florian M. Wurm and Maria de Jesus 11.1 Summary 327 11.2 Introduction 329 11.3 Process and Cells: The Quasi-species Concept Explains Individualized Development Needs 332 11.4 Choices for Manufacturing: Host Cells for Production and Suitable Selection Systems 335 11.5 Methods for Rapid Generation of High-Producing Cell Lines 337 11.6 Silencing: Stability of Expression, Facilitators for High-Level Productivity 339 11.7 High-Throughput Bioprocess Development 340 11.8 Disposable Bioreactors 342 11.9 Nonclonal Expression Technologies for Fast Production and Assessment of Expression Potential and Quality 343 11.10 Conclusions 345 Conflict of Interest 346 References 346 12 Process Development 355 ; Samuel D. Stimple and David W. Wood 12.1 Summary 355 12.2 Introduction 355 12.3 Protein A and Protein G Batch Affinity Chromatography 356 12.4 Alternatives to Protein A 358 12.5 Disposables and Continuous Downstream Processing 361 12.6 Conclusion 373 References 374 13 Biosimilars and Biobetters: Impact on Biopharmaceutical Manufacturing and CMOs 381 ; Ronald A. Rader 13.1 Summary 381 13.2 Introduction 382 13.3 The Biosimilar Pipeline 383 13.4 Developing Countries Will Continue to Prefer Cheaper Biogenerics 386 13.5 Biosimilar Candidates in the Pipeline 387 13.6 Biosimilar Development by Country/Region 387 13.7 Biosimilars Impact on Biopha
• Edition: 1st
• Publisher Details: Hoboken, New Jersey : John Wiley & Sons, Inc
• Publication Date: 2015
• Extent: 1 online resource, illustrations
• Subjects: 615.19; Drug development -- Methodology; Monoclonal antibodies
• Languages: English
• ISBNs: 9781118940631
• Related ISBNs: 9781118940624
• Notes: Note: Description based on CIP data; resource not viewed.
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