The patents of many of the blockbuster recombinant protein and monoclonal antibody (mAb) drugs have started to expire. This makes the market available for biosimilars i.e. highly similar versions of the originator biological drugs. The characteristics of a biological drug, e.g. charge variant profile, are determined to a large extent by the upstream expression system and conditions, and may be influenced by the purification process. Charge variant heterogeneity may be important for efficacy and safety of the drug and is therefore of interest to monitor and control during the production process.<br/><br/>The main purpose of this paper is to investigate the MAb charge variant separation in the polishing steps of the downstream chromatography process. Chromatography media screening, comparing traditional ion exchangers vs multi-modals, as well as a strategy for optimization of chromatographic conditions is presented. In addition, the impact of chromatography media characteristics, e.g. ligand density and particle size will be discussed. The effect of variation of the incoming cell culture material, on the charge variant separation, was also studied.

Evaluation of preparative ion exchange and multimodal chromatography for separation of charge variants in the mAb purification process

251st National Meeting (2016)

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