Characterization of Protein Therapeutics Using Mass Spectrometry

This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development. GUODONG CHEN, PHD, has extensive pharmaceutical research experience in major pharmaceutical companies, including Eli Lilly and Company, Schering-Plough and Bristol-Myers Squibb. Currently, he heads the analytical/mass spectrometry group at Bristol-Myers Squibb's Princeton site in support of drug discovery programs and development projects in small molecule pharmaceuticals and biologics. He has over 65 research publications in peer-reviewed journals and book chapters, and three edited/co-edited books in pharmaceutical analysis. His other contributions to the scientific community include over 80 presentations at scientific conferences and academic institutes; service as a short course instructor, as session chair at various scientific forums, and as a reviewer for journals. He received his Ph.D. in Analytical Chemistry from Purdue University under the direction of Professor R. Graham Cooks.  1  Introduction to Protein Mass Spectrometry 2   Quantitative Analysis of Therapeutic and Endogenous Peptides Using LC/MS/MS Methods  3   The Development and Implementation of LC/MS-based Bioanalytical Methods for the Quantification of Protein Therapeutics in Drug 4  Post-Translationally Modified Proteins: Glycosylation and Disulfide Bond Formation 5  Mass Spectrometric Characterization in Protein Therapeutics Discovery 6  Molecular Variants Characterization in Protein Therapeutics Development 7  Mass Spectrometry of Antibody-Drug Conjugates in Plasma and Tissue in Drug Development 8  Hydrogen / Deuterium Exchange Mass Spectrometry  for Protein Higher  Order Structure Characterization 9 Fast Photochemical Oxidation of Proteins for  Structural  Characterization 10 Applications of Ion Mobility Mass Spectrometry for Characterization of Protein Therapeutics