WEBINAR - Analytical workflows for charge variant analysis of monoclonal antibodies

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, Dr. Arnaud Delobel (R&D Director at Quality Assistance) 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. Visit https://www.quality-assistance.com/an... to download the slides ----- Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs. Technoparc de Thudinie, 2 6536 Donstiennes Belgium www.quality-assistance.com