Cation exchange chromatography (CEX) is perceived to be the gold standard for the charge sensitive characterisation of monoclonal antibodies (MAbs). Acidic and basic variants caused by chemical or enzymatic modifications can be separated from the main isoform of the MAb. These antibody variants have to be critically evaluated as differences in impurities and/or degradation products could lead to severe undesirable side effects.
In this application note, based on a comparative study performed by the University of Geneva, School of Pharmaceutical Sciences, four therapeutic MAbs of different species, isotypes and isoelectric point (pI) together with their variants were analysed using pH and salt gradient mode[1]. The non-porous YMC column BioPro IEX SF used for this study is an outstanding stationary phase for the characterisation of charge variants MAbs in CEX mode.
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