Optimizing chromatography and filtration for mAb virus clearance

Due to the high cost and complexity of using real viruses in process development, virus clearance is traditionally tested only in phase 1 and 3 clinical trials. By performing virus clearance at such a late stage in the development process, clearance often falls short of expectations (flow, throughput, log reduction value [LRV]) or even needs to be repeated under different conditions. In this work, we use surrogate viral particles to identify optimal clearance conditions during chromatography process development. This approach allows for de-risking prior to clinical trials. For virus filtration, we assess the impact of pushing the boundaries of the design space on virus clearance to accommodate a broad range of chromatography scenarios.

Speaker:
Mark Schofield