Continuous Biomanufacturing Implementation:Using an Intensified and Integrated Bioprocess Platform

摘要

Recent world events have demonstrated now more than ever the growing demand for pharmaceutical biologies that can be made rapidly and in high volumes yet somehow remain affordable. Hence, there is an urgent need to develop a next-generation biomanufacturing solution that provides high-yield, high-quality drug products and is highly flexible and cost-effective. Herein we describe the WuXi Biologies ultrahigh productivity platform (WuXiUP), an intensified perfusion culture process developed to meet theaforementioned need. WuXiUP adopts process-intensification strategies on to traditional perfusion culture processes to boost cell density and cell-specific productivity. The continuous harvest reduces greatly the residence time for a product within a bioreactor, leading to more desirable product quality and facilitating integrated continuous bioprocessing.