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Over the past ten years the pharmaceutical industry has investigated the development of drugs from biological molecules, e.g. proteins, which, due to their complexity, has been enabled by the very rapid advances in mass spectrometry (MS) and experimental approaches. This book provides a review of the state of the art for the in-depth characterization of these complex treatment modalities.
Coverage focuses on the use of mass spectrometry for the assessment of alternative modes of drug efficacy and their quality alongside the inclusion of information on the use of MS in the development of protein biosimilars. Providing a unique and up to date addition to the literature in this area, this book is aimed at researchers, both new and established, looking into the applications of MS in the pharmaceutical industry.
List of contents
Introduction to Mass Spectrometry of Biopharmaceuticals and Emerging Drug Modalities; Determination of Higher Order Structure in the Discovery and Development of Therapeutic Proteins; Use of Mass Spectrometry in the Quality Control Laboratory to Determine Multiple Product Attributes; Identification and Determination of Host Cell Proteins and Process Impurities; Approaches to Therapeutic Protein Bioanalysis; Characterization of Antibody-Drug Conjugates Quality Attributes; Bioanalysis and Biotransformation of Antibody-Drug Conjugates; Bioanalysis and Biotransformation of Oligonucleotide Drugs; Characterization and Bioanalysis of Cyclic and Constrained Peptidic Drugs; Subject Index
About the author
Mark Bolgar completed his PhD at the University of Manchester in 1997. He is now a Senior Research Fellow in the Drug Product Science and Technology Department of Bristol-Myers Squibb in New Brunswick, New Jersey. He currently leads the New Modalities and Biologics Team which supports formulation development of biologics and acts as a centre of excellence for the analytical development of new drug modalities such as peptides, ADCs and oligonucleotides. Having been involved in the application of mass spectrometry for more than 30 years, he has authored or co-authored 35 papers on the use of mass spectrometry in the areas of natural product identification, peptide characterization, identification and quantitation of drug impurities, bioanalysis, ambient ionization, and the characterization of conjugated proteins. He is also a co-inventor of a patented technique for ambient ionization mass spectrometry.
Summary
The focus of this book is on the use of mass spectrometry (MS) for the assessment of alternative modes of drug efficacy and inclusion of information on the use of MS in the development of protein biosimilars.
