The analytical characterisation of monoclonal antibodies is complex and requires a wide range of techniques, due to high heterogeneity of these proteins. This heterogeneity is due to post-translational modifications such as glycosylation, C-terminal lysine clipping, oxidation, deamidation, etc. Charge variant analysis is required to detect and quantify some of these modifications for characterisation purposes, for batch release or during stability studies.
Quality Assistance is equiped with state-of-the-art technologies for charge variant analysis, including ion-exchange chromatography and imaging capillary isoelectrofocusing (icIEF). These techniques can be run in a full GMP compliant environment and can therefore be used at the different stages of the development of a therapeutic monoclonal antibody.
During this live webinar, we will outline the different analytical workflows that can be used for charge variant analysis (ion-exchange chromatography with salt or pH gradients, MS-compatible approaches, 2D-LC/MS, and icIEF) and present several case studies.