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- Beck, Alain, et al. Show all 5 Authors
- Analytical chemistry 2017 v.89 no.3 pp. 2086-2092
- risk; reversed-phase liquid chromatography; monitoring; glycosylation; biopharmaceuticals; hydrophilic interaction chromatography; hydrophilicity; monoclonal antibodies; quality control; mass spectrometry; glycopeptides
- ... The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post-translational modifications (PTM) and thereby minimize the risk of being clinically meaningful differences between biosimilar and originator drug products. The glycosylation pattern of mAbs is considered to be ...