Characterizing Biotherapeutics

Analytical Methods for Diverse Modalities

Jennie R. Lill, Wendy Sandoval

• Publisher: Wiley
• Year: 2025
• Print ISBN: 9781394236114
• eBook ISBN: 9781394236138
• Edition: 1
• Topic: Physical Sciences
• Subtopic: Biochemistry

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.

Table of contents

• Cover
• Title Page
• Copyright
• Contents
• About the Editors
• List of Contributors
• Preface
• Chapter 1 Introduction
• Chapter 2 Analytical Characterization of Bispecific Antibodies and Bispecific Molecules
• Chapter 3 Analytical Challenges in Analyzing IgM Biotherapeutics
• Chapter 4 Mass Spectrometric Characterization of Therapeutic Recombinant Proteins
• Chapter 5 Therapeutic Proteins and Hyphenated Methods for Characterization
• Chapter 6 Methods for Characterization and Optimization of Peptide Therapeutics: Bioanalysis and Biotransformation
• Chapter 7 Structural Characterization of Biotherapeutics and New Modalities
• Chapter 8 Modern Methods for Characterizing the Higher‐Order Structure (HOS) of Biotherapeutics
• Chapter 9 Target Binding Assays for Biotherapeutics
• Chapter 10 Functional Assays for Screening Protein Biotherapeutics
• Chapter 11 Immunogenicity Profiling of Biotherapeutics (Wiley Book – Bioanalytical Characterization of New Therapeutic Modalities)
• Chapter 12 High‐Throughput Biophysical Assays for Developability Assessment
• Chapter 13 Establishing Analytical Methods for RNA‐Based Therapeutics Characterization
• Chapter 14 Analytical Methods Shaping Cell Therapy Characterization
• Chapter 15 Characterizing Nucleic Acid‐, Gene‐, and Cell‐Based Therapeutics with Sequencing Technologies
• Chapter 16 Mass Spectrometry‐Based Methods to Investigate Protein–Protein Interactions in Cells and Their Application in Drug Discovery
• Chapter 17 Receptomics and Extracellular Interactomics for Biotherapeutic Characterization
• Chapter 18 Membrane Proteins: Challenging Biotherapeutic Targets
• Chapter 19 Chemoproteomics Approaches for Diverse Modalities
• Chapter 20 Drug Delivery Modalities and Mechanisms
• Index
• EULA