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Full Description
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.
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
