Overview

Provides detailed and up-to-date coverage of analytical approaches for biologic drug modalities The development of innovative biologic therapies has revolutionized medicine, but their complexity demands equally advanced analytical approaches. Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities introduces the tools and techniques used to analyze these groundbreaking therapies. Designed to help readers characterize and troubleshoot increasingly diverse and sophisticated therapeutic molecules, this in-depth guide addresses different biologic drugs, their unique analytical challenges, and the methods that enable their analysis. Organized into two comprehensive sections, Characterizing Biotherapeutics first delves into the fundamentals of analytical platforms, providing a robust foundation in techniques such as mass spectrometry and biophysical assays. The second section applies these methods to real-world scenarios, focusing on drug discovery, clinical evaluation, and commercial considerations in drug development. Authors Jennie R. Lill and Wendy Sandoval provide clear guidance tailored to the evolving demands of therapeutic innovations such as structural characterization, high-throughput biophysical assays, and RNA-based therapeutics. Equipping researchers with the knowledge to navigate the challenges posed by increasingly complex biologics, Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities: Discusses new and emerging biological molecule diversity and both traditional analytical methods Provides characterization strategies for large molecule (protein/antibody) based therapeutics Summarizes cutting-edge technologies for novel modalities and antibody protein therapeutics Incorporates the latest advancements in mass spectrometry, functional assays, and biophysical methods Addresses specialized analytical issues for membrane proteins and other challenging targets Presents methodologies for assessing safety and therapeutic potential Characterizing Biotherapeutics: Analytical Methods for Diverse Modalities is an essential reference for analytical scientists, biologists, and mass spectrometrists involved in biomolecule analysis. It is also a valuable resource for graduate students taking advanced courses in biotechnology, drug development, and biotherapeutic analysis, as well as professionals in biotechnology and pharmaceutical industries working to advance biotherapeutic research and development.

Full Product Details

Author:   Jennie R. Lill (Genentech) ,  Wendy Sandoval (Genentech)
Publisher:   John Wiley & Sons Inc
Imprint:   John Wiley & Sons Inc
Weight:   1.588kg
ISBN:  

9781394236114

ISBN 10:   1394236115
Pages:   480
Publication Date:   28 July 2025
Audience:   Professional and scholarly ,  College/higher education ,  Professional & Vocational ,  Postgraduate, Research & Scholarly
Format:   Hardback
Publisher's Status:   Active
Availability:   Out of stock  
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Table of Contents

About the Editors xvii List of Contributors xix Preface xxv 1 Introduction 1 Alissa D. Guarnaccia, Wendy Sandoval, and Jennie R. Lill 2 Analytical Characterization of Bispecific Antibodies and Bispecific Molecules 7 Michael Dillon, T. Noelle Lombana, and Christoph Spiess 3 Analytical Challenges in Analyzing IgM Biotherapeutics 29 Amber D. Rolland and Albert J.R. Heck 4 Mass Spectrometric Characterization of Therapeutic Recombinant Proteins 55 Alissa D. Guarnaccia, Corey E. Bakalarski, Wendy Sandoval, and Jennie R. Lill 5 Therapeutic Proteins and Hyphenated Methods for Characterization 71 Dietmar Reusch and Markus Haberger 6 Methods for Characterization and Optimization of Peptide Therapeutics: Bioanalysis and Biotransformation 85 Phillip Chu, Suk-Joon Hyung, Robert S. Jones, S. Cyrus Khojasteh, Dennis H. Leung, Bin Ma, Huy Nguyen, Emile Plise, Ola M. Saad, John C. Tran, Qinying Yu, and Xing Zhang 7 Structural Characterization of Biotherapeutics and New Modalities 109 Paola Di Lello and Patrick Lupardus 8 Modern Methods for Characterizing the Higher-Order Structure (HOS) of Biotherapeutics 129 Felix Kuhne, Rachel P. Liu, Lingfei Wang, Aaron T. Wecksler, Manasi Gaikwad, Christine C. Jao, Alberto Estevez, Roshan M. Regy, and Saeed Izadi 9 Target Binding Assays for Biotherapeutics 161 Eric Janezic and Xiangdan Wang 10 Functional Assays for Screening Protein Biotherapeutics 175 Maureen Beresini and Kelly Loyet 11 Immunogenicity Profiling of Biotherapeutics (Wiley Book - Bioanalytical Characterization of New Therapeutic Modalities) 197 Qui T. Phung, M. Violet Lee, Ola Saad, Sivan Cohen, Yinyin Li, Mercedesz Balasz, Jieming Chen, Zhaojun Yin, Zhenru Zhou, and Jennie R. Lill 12 High-Throughput Biophysical Assays for Developability Assessment 223 Emma Pelegri-O’Day and Nithya Srinivasan 13 Establishing Analytical Methods for RNA-Based Therapeutics Characterization 243 Julien Camperi, Emily Freund, Carolina Galan, and Axel Guilbaud 14 Analytical Methods Shaping Cell Therapy Characterization 261 Amritha Lewis, Sadhu Sudeshna, Melmon Rebecca, Shaik Rahamthulla, Tutuncuoglu Egemen, and Gilbert Amy 15 Characterizing Nucleic Acid-, Gene-, and Cell-Based Therapeutics with Sequencing Technologies 271 Hayley M. Bennett, Ashley Byrne, William Stephenson, and Zora Modrusan 16 Mass Spectrometry-Based Methods to Investigate Protein-Protein Interactions in Cells and Their Application in Drug Discovery 289 Tess Branon 17 Receptomics and Extracellular Interactomics for Biotherapeutic Characterization 321 Naincy R. Chandan, Abel Ferrel, and Shengya Cao 18 Membrane Proteins: Challenging Biotherapeutic Targets 341 Hiruni S. Jayasekera, Farhana Afrin Mohona, and Michael T. Marty 19 Chemoproteomics Approaches for Diverse Modalities 365 H. Christian Eberl, Sascha Knecht, Markus A. Queisser, and Marcus Bantscheff 20 Drug-Delivery Modalities and Mechanisms 385 Yu Tong Tam, Madyson Migliozzi, Devin B. Tesar, Amin Famili, Aaron T. Wecksler, Sara Wichner, Alavattam Sreedhara, and Whitney Shatz-Binder Abbreviations 421 References 422 Index 439

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Author Information

Jennie R. Lill, PhD, is the Executive Director of the Proteomic and Genomic Technologies Department at Genentech, where she has worked since 2004. With over 90 peer-reviewed publications and three books, including Analytical Characterization of Biotherapeutics, her work focuses on cutting-edge analytical techniques in drug discovery and development. Wendy Sandoval was the Director of Translational Mass Spectrometry in Research at Genentech, where she had been a pivotal contributor for over 30 years. She has authored more than 100 scientific publications and co-authored two books, including Analytical Characterization of Biotherapeutics. She now runs a plant nursery and botanical garden in Northern California (https://botanicanurseryandgardens.com/) and enjoys playing in dirt.

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