Bioanalytical Aspects in Biological Therapeutics

ISBN-13: 9781119523215 / Angielski / Twarda / 2022 / 352 str.

Xiaohui (Sophia) Xu; Weifeng Xu; Mike S. Lee

Spis treści

Preface viiXiaohui Xu and Weifeng XuForeword ixBinodh DeSilvaAcknowledgments xiiiAbout the Editors xvList of Contributors xvii1 Overview of the Development of Biotherapeutics and the Role of Bioanalytical Sciences 1Robert Dodge2 Basic Immunology for Bioanalytical Testing of Biotherapeutics 23Kang Chen and Weifeng Xu3 Platform and Instrument Considerations in Bioanalytical Testing 51Dominic Warrino and Franklin Spriggs4 Pharmacokinetic Assays 67Tong-Yuan Yang and Eric Wakshull5 Recent Progress in Biomarker Bioanalysis and Target Engagement Assessment 87Yan G. Ni, Lindsay E. King and Carmen Fernández-Metzler6 Immunogenicity Risk Assessment for Biotherapeutics 141Jochem Gokemeijer7 Bioanalytical Strategy to Support Clinical Immunogenicity Assessment: Anti-drug Antibodies 159Ying Wang and Michael Luong8 Bioanalytical Scheme for Antidrug Neutralizing Antibody Assays 185Weifeng Xu, Bonnie Wu and Jim McNally9 Critical Reagents in Bioanalysis 209Yang Xu, Agostinho Gomes Rocha, Shannon Chilewski, Krisna C. Duong-Ly, Kun Yang and Jonathan Haulenbeek10 Statistical Aspects of Bioanalytical Testing 239Arkady M. Gershteyn and Mark Ma11 Bioanalytical Aspects in Biological Therapeutics: Biotransformation 277Wenying Jian, Cong Wei and Jinping Gan12 New Modalities: Multidomain Therapeutics and Gene Therapy Programs 309Kelly Colletti and Mark Ma13 Regulatory Aspects for Assay Development, Validation, and Sample Analysis 327Amy Lavelle and Megan WibergIndex 355

O autorze

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.