期刊
CURRENT OPINION IN BIOTECHNOLOGY
卷 71, 期 -, 页码 32-40出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.copbio.2021.05.008
关键词
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Intact protein analysis using mass spectrometry is a well-established method for characterizing biotherapeutics, but chromatographic separation is necessary due to the complexity of recombinant proteins. Recent progress has been made in coupling liquid chromatography-based native separation modes with mass spectrometry, enabling rapid assessment of molecular mass and deep characterization of heterogeneity in therapeutic proteins.
Intact protein analysis by means of mass spectrometry has become a well-established method for the characterization of biotherapeutics. However, due to the highly complex nature of recombinant proteins, prior chromatographic separation is inevitable for a comprehensive analysis. In recent years, progress in coupling a variety of liquid chromatography-based native separation modes such as size exclusion, ion exchange and hydrophobic interaction chromatography to mass spectrometry (native LC-MS) has been reported, therefore allowing for rapid assessment of molecular mass and deep characterization of the heterogeneity of complex, recombinantly produced therapeutic proteins. Here we provide a comprehensive overview of recent advances in the development and application of native LC-MS for biopharmaceutical characterization.
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