Improving an intensified and integrated continuous bioprocess platform for biologics manufacturing.

Abstract

The WuXi Biologics' Ultra-high Productivity platform (WuXiUP) technology is an innovative and integrated platform of continuous biomanufacturing. Through process intensification, the platform enables continuous manufacturing of almost any type of biologics and delivers processes with ultra-high productivity. In this paper, a new case study producing a monoclonal antibody (mAb) via the WuXiUP process was further optimized. Key process parameters like culture temperature, basal media, and perfusion rate were evaluated to ensure an enhanced and robust process. To improve process efficiency for downstream processing, a continuous dual-pore size hollow fiber cell separation and product harvest system were also designed to complement the increased harvest volume from upstream production. In this case study, a significant protein concentration increase and harvest volume reduction were achieved by the application of the new WuXiUP platform.