Main description:

In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Contents:

Contents to Volume 1 Preface XVII A Personal Foreword XXI Acknowledgements XXIII Part I Introduction to Protein Therapeutics: Past and Present 1 1 Early Recombinant Protein Therapeutics 3 Pierre De Meyts 2 Evolution of Antibody Therapeutics 25 Herve Watier and Janice M. Reichert Part II Antibodies: The Ultimate Scaffold for Protein Therapeutics 51 3 Human Antibody Structure and Function 53 Ponraj Prabakaran and Dimiter S. Dimitrov 4 Antibodies from Other Species 85 Melissa L. Vadnais, Michael F. Criscitiello, and Vaughn V. Smider Part III Discovery and Engineering of Protein Therapeutics 113 5 Human Antibody Discovery Platforms 115 William R. Strohl 6 Beyond Antibodies: Engineered Protein Scaffolds for Therapeutic Development 161 Nishant K. Mehta and Jennifer R. Cochran 7 Protein Engineering: Methods and Applications 189 Claire Dobson 8 Bispecifics 229 Jijie Gu, Andrew McCluskey, and Tariq Ghayur 9 Antibody drug Conjugates (ADCs) 271 Dr Philip W. Howard Contents to Volume 2 Preface XVII A Personal Foreword XXI Acknowledgements XXIII Part IV Physiological and Manufacturing Considerations for Biologics 311 10 Pharmacokinetics of Therapeutic Proteins 313 Zheng Lu, Jennifer Sheng, and Wenhui Zhang References 334 11 Safety Considerations for Biologics 341 Maggie Dempster, Lucinda R. Weir, and Rajni S. Fagg 12 Immunogenicity of Biologics 387 Matthew P. Baker, Timothy D. Jones, and Paul Chamberlain 13 Expression Systems for Recombinant Biopharmaceutical Production by Mammalian Cells in Culture 423 Adam J. Brown, Devika Kalsi, Alejandro Fernandez-Martell, Joe Cartwright, Nicholas O. W. Barber, Yash D. Patel, Richard Turner, Claire L. Bryant, Yusuf B. Johari, and David C. James Abbreviations 450 References 452 14 Stability, Formulation, and Delivery of Biopharmaceuticals 469 Hanns-Christian Mahler and Andrea Allmendinger Part V Clinical Applications 493 15 Protein Therapeutics in Autoimmune and Inflammatory Diseases 495 Anthony J. Coyle and Leigh S. Zawel References 511 16 Antibody-Based Therapeutics in Oncology 521 Paul A. Moore, Ross La Motte-Mohs, Jonathan C. Li, and Gurunadh R. Chichili 17 Protein Therapeutics in Respiratory Medicine 587 Rahul Shrimanker and Ian D. Pavord 18 Antibodies for the Prevention, Treatment, and Preemption of Infectious Diseases 611 Steve Projan 19 Rescue Therapies 621 Stephan Glund 20 Biosimilars 645 Jun Wang Part VI Future Horizons 661 21 Future Horizons and New Target Class Opportunities 663 Herren Wu, Carl Webster, Judy Paterson, Sandrine Guillard, Ron Jackson, and Ralph Minter References 690 Index 701