WuXi Biologics achieves pilot-scale automated continuous drug substance production

Shanghai-based WuXi Biologics, a global contract research, development and manufacturing organization (CRDMO), announced its intensified perfusion culture process platform, WuXiUP, has achieved end-to-end, fully automated continuous drug substance production at pilot scale. The company said the system will be deployed across its major GMP facilities to improve manufacturing efficiency and flexibility.

According to the CRDMO, the automated platform enables continuous 24/7 operation, which reduces manual intervention and quality risks. In upstream processes, the company reported that 24 days of continuous cell culture produced yields exceeding 110 g/L, with a peak daily yield of 7.6 g/L. For downstream purification, WuXiUP uses a two-step membrane chromatography system that reportedly delivers a five- to ten-fold increase in productivity compared to resin-based stationary phases. 

The system reportedly integrates process analytical technology for real-time monitoring of protein purity, concentration, pH and conductivity, and uses residence time distribution to divert out-of-specification samples.

This latest milestone adds to WuXi Biologics’ recent manufacturing and supply chain initiatives. Earlier this week, the company announced the launch of WuXiUI, a stable cell line platform that it said can shorten timelines for biologics development and manufacturing. 

In late July, WuXi Biologics also revealed it had begun construction on a modular drug product manufacturing facility in Singapore designed to support flexible, small-batch production for both clinical and commercial supply.