ANALYTICAL CHARACTERIZATION OF BIOTHERAPEUTICS

1 Introduction to Biotherapeutics 1
2 Mass Spectrometric Characterization of Recombinant Proteins 15
3 Characterizing the Termini of Recombinant Proteins 43
4 Assessing Activity and Conformation of Recombinant Proteins 73
5 Structural Characterization of Recombinant Proteins and Antibodies 111
6 Antibody de novo Sequencing 139
7 Characterization of Antibody–Drug Conjugates 155
8 Characterization of Bispecific or Other Hybrid Molecules 169
9 Bio-Repository 199
10 Characterization of Residual Host Cell Protein Impurities in Biotherapeutics 211
11 Analytical Tools for Biologics Molecular Assessment 239
12 Glycan Characterization: Determining the Structure, Distribution, and Localization of Glycoprotein Glycans 257

The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research
Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions.
The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more.
• Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents
• Covers the full range of characterization strategies for large molecule based therapeutics
• Provides an up-to-date account of the latest approaches used for large molecule characterization
• Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization
Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.

Author Information
• JENNIE R. LILL, PhD is Director of Proteomics at Genentech, where she is responsible for the management of Genentech's Microchemistry, Proteomics & Lipidomics Department. Dr. Lill has been involved in the experimental design and technological innovation of biological mass spectrometry for more than two decades.
• WENDY SANDOVAL leads the Applied Proteomics group at Genentech where she is responsible for the management and oversight of native mass spectrometry, antibody characterization, lipidomics and the core mass spectrometry group.