High throughput platform and automated sample preparation for host cell protein analysis to support downstream process development
Host cell Proteins (HCPs) are process related impurities typically monitored using immunological techniques such as enzyme-linked-immunosorbent assay (ELISA). HCPs may result in adverse events in patients or impact product potency and stability, depending on their identity and quantities. As the final residual amount needs to be assessed for the product quality and aims to reach a minimal level, effective HCPs clearance is of the main objective for process development. In this context analytical demands during process development are steadily growing triggering more HCPs quantity determinations.
A high throughput platform using the Gyrolab® xP workstation and Gyrolab CHO-HCP E3G kit has been successfully developed and implemented in Sanofi to be able to support accelerated bioprocess development. Moreover, sample preparation is still a time-consuming step. Therefore automated sample dilution step was developed using the Bravo platform (Agilent) to increase throughput, increase results confidence, reduce dilution error, hands-on time and eventually reduce the time to introduce new molecules in clinical studies.