Bioanalytical Aspects in Biological Therapeutics

Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.

Preface vii Xiaohui Xu and Weifeng Xu Foreword ix Binodh DeSilva Acknowledgments xiii About the Editors xv List of Contributors xvii 1 Overview of the Development of Biotherapeutics and the Role of Bioanalytical Sciences 1 Robert Dodge 2 Basic Immunology for Bioanalytical Testing of Biotherapeutics 23 Kang Chen and Weifeng Xu 3 Platform and Instrument Considerations in Bioanalytical Testing 51 Dominic Warrino and Franklin Spriggs 4 Pharmacokinetic Assays 67 Tong-Yuan Yang and Eric Wakshull 5 Recent Progress in Biomarker Bioanalysis and Target Engagement Assessment 87 Yan G. Ni, Lindsay E. King and Carmen Fernández-Metzler 6 Immunogenicity Risk Assessment for Biotherapeutics 141 Jochem Gokemeijer 7 Bioanalytical Strategy to Support Clinical Immunogenicity Assessment: Anti-drug Antibodies 159 Ying Wang and Michael Luong 8 Bioanalytical Scheme for Antidrug Neutralizing Antibody Assays 185 Weifeng Xu, Bonnie Wu and Jim McNally 9 Critical Reagents in Bioanalysis 209 Yang Xu, Agostinho Gomes Rocha, Shannon Chilewski, Krisna C. Duong-Ly, Kun Yang and Jonathan Haulenbeek 10 Statistical Aspects of Bioanalytical Testing 239 Arkady M. Gershteyn and Mark Ma 11 Bioanalytical Aspects in Biological Therapeutics: Biotransformation 277 Wenying Jian, Cong Wei and Jinping Gan 12 New Modalities: Multidomain Therapeutics and Gene Therapy Programs 309 Kelly Colletti and Mark Ma 13 Regulatory Aspects for Assay Development, Validation, and Sample Analysis 327 Amy Lavelle and Megan Wiberg Index 355