Bioanalytical Aspects in 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 publications 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., Inc. 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