Application Note on mAb Polishing Platform Intensification

This application note presents a study focused on intensifying the monoclonal antibody (mAb) polishing platform to enhance efficiency in time, cost, and space. It outlines the challenges faced in chromatography operations due to rising mAb titers and the need for process intensification to improve productivity and reduce costs. The document details a collaborative effort with Enzene Biosciences Ltd. to demonstrate how a batch mAb purification process can be transformed into a stepwise intensified process using Sartobind® Q and CMM HyperCel™. This approach aims to eliminate intermediate steps and achieve significant cost reductions during secondary purification. The note further explains various levels of process intensification strategies, from basic batch processes to continuous processes, and highlights the advantages of membrane chromatography over traditional resin-based methods. The findings suggest that these innovations can lead to improved facility utilization and lower buffer consumption, ultimately addressing the bottlenecks in traditional mAb purification processes.