Strategies for downstream purification of monoclonal antibodies typically include one or more ion exchange steps, such as cation exchange or anion exchange. Optimization of the cation exchange step may include the utilization of a salt gradient to determine optimal elution conditions in order to remove sufficient process or product related impurities. During the re-development of a monoclonal antibody purification process, a unique process derived charge variant was enriched in fractionated CEX eluate, which provided an effective method to investigate the interplay between this charge variant and disulfide isoform.  In this study, we describe the distribution of this unique monoclonal antibody charge variant, and demonstrated an integrated approach to investigate disulfide isoform and charge variant interaction for IgG2 monoclonal antibody process development.<br/>

Distribution of a unique process derived charged monoclonal antibody species across a cation exchange column

255th National Meeting (2018)

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