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.

Xiaohui Xu, PhD, is Director at Daiichi Sankyo Inc. She is actively serving in the American Association of Pharmaceutical Scientists (AAPS) PK Assay Group and IQ Consortium Metabolite Working Group. She has extensive experiences in regulated bioanalytical field including global submissions, covering small molecules, biologics and new modalities. She has extensive publicaitons and 2 book chapters. She received her Doctorate in Pharmaceutical Analysis from College of Pharmacy, the University of Georgia.

Weifeng Xu, PhD, is Director at Merck Co. He is an active member and leader in the AAPS and the European Bioanalysis Forum’s (EBF) immunogenicity community and has published multiple papers on immunogenicity assay development and validation. He is also co-leading the IQ Consortium Bioanalytical Considerations and Challenges for Cell Therapies subgroup. More recently Weifeng also became Bioanalytic lead to multiple vaccine projects within Merck including COVID-19 and pneumococcal to oversee all clinical immunogenicity assays.

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

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.