- WuXi Biologics has achieved fully automated, continuous drug substance production at pilot scale using its intensified perfusion culture platform, WuXiUP™.
- The platform will be implemented across the company’s major GMP facilities to improve efficiency, flexibility, and quality control for global clients.
WuXi Biologics has reported that its WuXiUP™ intensified perfusion culture process has reached a milestone with end-to-end, fully automated continuous drug substance production at pilot scale. The platform will be deployed across the company’s major GMP manufacturing sites to enhance efficiency and flexibility for clients developing innovative therapies.
The automated system enables 24/7 continuous operation, reducing manual intervention and potential quality risks. In upstream processing, WuXiUP™ delivers extended 24-day cell culture runs, producing more than 110 g/L in total, with peak daily yields of 7.6 g/L. Downstream purification is conducted via a two-step, high-efficiency membrane chromatography system, which achieves a five- to tenfold productivity increase compared with traditional resin-based stationary phases.
Quality control is reinforced through advanced Process Analytical Technology (PAT), which provides real-time monitoring of parameters such as protein purity, pH, and conductivity in Harvested Clarified Cell Culture Fluid. The integration of a closed-loop control system and Residence Time Distribution analysis enables the diversion of out-of-spec material, strengthening process consistency.
Dr Chris Chen, CEO of WuXi Biologics, said: “The WuXiUP™ platform has already proved its technical maturity and viability in commercial manufacturing. And now it has reached another significant milestone: accomplishing fully automated continuous DS production at pilot scale.”
