Protein A affinity chromatography is used as the capture step for a monoclonal antibody in late-stage development. In order to validate and commercialize this step, it is necessary to characterize the process through identification of the input process parameters that affect product quality and process performance. Based on a risk assessment approach, the likelihood of each input process parameter to affect product quality and process performance was determined. From this assessment, protein load (g/L resin), residence time (minutes), wash volume (CVs), elution pH, and collection criteria (OD) were selected for evaluation. A Design of Experiments (DOE) study with 34 runs was designed using JMP statistical analysis software to determine the effect of these input parameters on product quality and process performance attributes. Experiments were performed sequentially on small-scale columns using an AKTA-FPLC system. Additionally, in an effort to expedite timelines and reduce resource consumption, the DOE study was also miniaturized and automated using a Tecan Freedom Evo liquid handling robot with Atoll RoboColumns. This enabled the reduction of the study duration from 2 weeks to 2 days. Product quality and process performance results from the traditional column and the Atoll Robocolumn runs will be presented and discussed.<br/>Abbreviations: CV = column volume, OD = optical density; FPLC = fast protein liquid chromatography

Automated scale-down model of a commercial chromatography process

249th National Meeting (2015)

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