Cation exchange chromatography (CEX) is an important step in the purification of some biologics such as monoclonal antibodies (mAb). Commercial Process Development and Process Characterization require a large set of experiments to establish desirable operating conditions. Lately, the biopharma industry has shifted toward developing mechanistic numerical models that can be calibrated with a limited set of experimental runs and are able to accurately predict process conditions. These mechanistic models enable the characterization of process robustness and help establishing a design space that ensures product quality by the means of high performance computing. <br/> <br/>In this talk, we present the development of a highly predictive model for a mAb CEX process. The model uses a novel pH dependent multi-state steric mass action isotherm, calibrated with a limited set of targeted bench scale experiments. The model is validated against a larger set of bench scale experiments. Finally, we apply the model to the commercial scale, the results of which can be used for regulatory filing.<br/>

In-silico model formulation, calibration and application for commercial CEX chromatography

255th National Meeting (2018)

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