Abstract
N-glycan, a critical quality attribute (CQA) of monoclonal antibodies, profoundly impacts potency, immunogenicity, safety, and clinical efficiency. Therefore, N-glycan should be monitored and controlled during development. The conventional 2-AB method is considered the gold standard for N-glycan analysis, which is labor intensive and time consuming. Moreover, its sample requirement is relatively high and cannot be met in early-stage development, including cell line development. In this study, we compared the performance of four rapid analytical methods in N-glycan analysis of mAbs, including the rapid 2-AB method, reduction method, off-line IdeS digestion method, and two-dimensional liquid chromatography-mass spectrometry (2D-LC-MS) method. Our results showed that these four rapid analytical methods could provide comparable N-glycan data. Moreover, these four rapid methods shortened the testing time for the conventional 2-AB method from days to just minutes. They also reduced the sample requirement for the conventional 2-AB method from milligrams to micrograms. Among these four rapid methods, the 2D-LC-MS method demonstrated great potential for applications in time-consuming cell line development because it required less testing time and a lower sample requirement.
Published Version
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