Recovery & Purification
Flow-Through Versus Bind-And-Elute: An Alternative Strategy for Improved Robustness and Manufacturability for a Challenging Cation Exchange Chromatography
Cation exchange chromatography (CEX) operated in bind-and-elute mode is a common polishing step for removal of aggregates in purification processes of biopharmaceuticals. Depending upon the resolution of the product and the aggregates, the operating ranges for process parameters providing the acceptable clearance can be narrow. This requires tight manufacturing process controls to ensure consistent product quality and process performance. This presentation will show a case study using a monoclonal antibody with cation exchange chromatography operated in flow-through mode, resulting in a more “manufacturing-friendly” purification approach and robust alternative. The flow-through CEX was able to provide high aggregate clearance and step yield, comparable to or better than the bind-and-elute CEX method, over wider ranges of process parameters and with fewer critical process parameters for the control strategy of this step. The presentation will also illustrate advantages of flow-through CEX on manufacturing throughput, raw material consumption, and improved manufacturing process fit over bind-and-elute CEX. Data on process robustness of the flow-through CEX to resin variability versus the bind-elute CEX mode of operation will also be included.