(279b) High Throughput Process Development for CEX Chromatography

Chromatographic operations are the workhorse for protein purification in the biopharmaceutical industry due to their unparalleled separation efficiency and capacity. Typically, chromatographic processes consist of multiple polishing steps, at least one of which is operated in a bind and elute mode. Although bind and elute chromatography is very effective at removing product variants, it suffers from limited capacity and long processing times. In this work, we developed efficient cation exchange chromatography (CEX) flowthrough steps for mAbs using a combination of high throughput screens and lab scale experiments. CEX resins were screened across parameter space using high throughput screening techniques. Conditions which improved process performance as compared to a bind and elute operation were identified. Following high throughput screening, this process was evaluated at the lab scale for further development and refinement. Comparable product quality and process consistency between the Tecan and the lab scale experiments suggest an efficient and reliable high-throughput process development workflow for CEX flowthrough operations.