By leveraging its ultra-intensified fed-batch platform, WuXiUITM, WuXi Biologics has completed its first scale-up to 2,000L drug substance (DS) GMP manufacturing, achieving a 4-fold productivity improvement compared to the traditional fed-batch process The competitive performance achieved through the utilization of both WuXiUITM and the proprietary platform cell culture media MagniCHOTM led to significant reduction in overall DS manufacturing COGS The consistent performance of WuXiUITM – from small scales to 2,000L GMP manufacturing – is a testament to the advancement of the technology as a mature and robust platform capable of significantly improving the cost-effectiveness of biologics production SHANGHAI , Aug. 30, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has successfully accomplished 2,000L drug substance (DS) GMP manufacturing by utilizing its proprietary ultra-intensified fed-batch bioprocessing platform WuXiUITM.
The platform achieved a titer of 18 g/L, a 4-fold increase compared to conventional fed-batch process, demonstrating the high efficiency of WuXiUITM in improving productivity. In addition, the company's enhanced downstream technology platform enabled doubled purification processing capacity and similar impurity removal, which resulted in a 50% reduction in downstream processing time and a final DS yield of 70% with comparable pr.