Characterizing Biotherapeutics
Analytical Methods for Diverse Modalities
1. Edition July 2025
480 Pages, Hardcover
Wiley & Sons Ltd
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.
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
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.