Biopharmaceutical quality control with mass spectrometry

Liu S, Schulz BL | Bioanalysis, 13(16), 1275–1291 (2021) Keywords: biopharmaceutical quality control • host-cell proteins • mass spectrometry • protein post-translational modifications • protein structure Mass spectrometry (MS) is a powerful technique for protein identification, quantification and characterization that is widely applied in biochemical studies, and which can provide data on the quantity, structural integrity and post-translational modifications of proteins. It is therefore a versatile and widely used analytic tool for quality control of biopharmaceuticals, especially in quantifying host-cell protein impurities, identifying post-translation modifications and structural characterization of biopharmaceutical proteins. Here, we summarize recent advances in MS-based analyses of these key quality attributes...

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