Description
Book SynopsisBioanalytical 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 th
Table of ContentsPreface 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
