Characterizing Biotherapeutics

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.

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.