Proof of Concept for Connected Downstream Process

This technical report presents a proof-of-concept study for a connected downstream process in biomanufacturing, focusing on the purification of monoclonal antibodies (mAbs). The study addresses the challenges faced in the production of mAbs, particularly those produced at high expression titers, which complicate downstream processing. The report details the implementation of process intensification strategies, including connected processing and various chromatography techniques, to enhance productivity and efficiency. The methodology section outlines the design and testing of a custom chromatography system that integrates multiple purification steps, including viral inactivation and filtration. The results indicate that the connected process successfully completed four cycles within five hours, although minor adjustments were needed to manage pressure during filtration. The report concludes with insights into the operational benefits of connected processing and the potential for increased throughput in biomanufacturing settings.