Assessment of monoclonal antibody glycosylation: a comparative study using HRMS, NMR, and HILIC-FLD
Joshua Shipman,
Michael Karfunkle,
Hongbin Zhu
et al.
Abstract:Monoclonal antibodies (mAbs) represent the largest class of therapeutic protein drug products. mAb glycosylation produces a heterogeneous, analytically challenging distribution of glycoforms that typically should be adequately characterized because glycosylation-based product quality attributes (PQAs) can impact product quality, immunogenicity, and efficacy. In this study, two products were compared using a panel of analytical methods. Two high-resolution mass spectrometry (HRMS) workflows were used to analyze… Show more
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