(410b) Scale down Model Demonstrates High Prodcut Throughputs with Disposable Anion Exchange Chromatography

Anion exchange (AEX)chromatography is commonly used as a unit operation for trace contaminant removal and virus clearance during large scale monoclonal antibody production. AEX resins are traditionally used for this process application in the flow through mode. However, disposable AEX membrane chromatography offers a unique advantage with regard to capacity/flux relations. Membrane chromatography performance rivals resin performance but with significantly smaller membrane volumes and at greater flow rates. This translates into higher throughput capacities with membrane chromatography devices. These high throughput amounts & flow rates justify the use of AEX membranes in large scale manufacturing. In order to affirm high throughputs at process scale, a novel scale down model was developed for accurate scale up of virus clearance and process evaluation data. The membrane is in cylindrical format and parallels large scale device design. Additionally, the design allows aggressive throughput and flow rates during chromatography applications. Scale down virus clearance studies and evaluations were conducted to determine the threshold limit of product load. Results from these studies demonstrate that virus clearance and trace contaminant removal values are suitable for production standards. Scalability was signified with similar performance at process scale. High throughput amounts at accelerated flow rates and disposability translate into increased process efficiency.