Aggregation is a major concern for therapeutic monoclonal antibody (mAb), as aggregates reduce drug efficacy and safety. In addition to aggregation control, aggregate removal by downstream processing is crucial. Hydrophobic and mixed-mode resins are widely used for aggregate removal in different cases, but they are seldom compared side by side. In this study, the aggregate removing capability of eight resins belonging to different chromatographic types was demonstrated by a case study. This work, by providing multiple options for aggregate removal, allows more flexibility to be gained in downstream processing.
Keywords: Aggregate removal; Antibody aggregate; Hydrophobic interaction chromatography (HIC); Hydroxyapatite (HA); Mixed-mode resin; Polyethylene glycol (PEG).
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