WuXi Biologics' WuXiUP™ Accomplishes Automated Continuous Drug Substance Production at Pilot-Scale

• Building on its success in developing continuous production at pilot-scale with the WuXiUP™ platform, WuXi Biologics has further enhanced the technology to achieve automated continuous drug substance (DS) manufacturing at pilot-scale. This advancement integrates industry-leading technologies, including membrane chromatography and automated control systems, along with iterative enhancements to Process Analytical Technology (PAT).
  
  
• The WuXiUP™ automated continuous production platform will deliver greater value as it boosts manufacturing efficiency and product quality, enabling clients to accelerate the journey of their innovative therapies from development to commercialization.

SHANGHAI, Aug. 12, 2025 /CNW/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that its intensified perfusion culture process platform, WuXiUP™, has achieved end-to-end, fully automated continuous drug substance（DS）production at pilot scale. The automated continuous production platform will be deployed across the company's major GMP facilities, offering clients greater efficiency and flexibility to accelerate the journey of their innovative therapies from development to commercialization.

By fully integrating an automated system, the continuous production platform enables non-stop 24/7 operation, which minimizes manual intervention, reduces quality risks, and enhances manufacturing efficiency. In upstream processes, WuXiUP^TM has accomplished exceptional performance: 24 days of continuous cell culture yields a total output that exceeds 110 g/L, with a peak daily yield of 7.6 g/L. For downstream purification, WuXiUP™ incorporates a two-step, high-efficiency membrane chromatography system. Compared to traditional resin-based stationary phases, this technology enables faster mass transfer, delivering a 5- to 10-fold increase in productivity.

To strengthen quality control throughout downstream continuous purification, WuXiUP™ employs advanced, iteratively improved Process Analytical Technology (PAT), which provides real-time monitoring and feedback on critical parameters in Harvested Clarified Cell Culture Fluid (HCCF), including protein purity, concentration, pH, and conductivity. When integrated with the automated closed-loop control system, the technology utilizes Residence Time Distribution (RTD) analysis to intelligently divert out-of-spec samples, significantly enhancing manufacturing procedure control.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "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. Such achievements underscore WuXi Biologics' steadfast dedication to furthering technological innovation, and advancing the standards for digitalization and automation in biopharmaceutical R&D and manufacturing — both of which are critical capabilities to improve quality and accelerate timelines. With our deep technical expertise and extensive track record, WuXi Biologics remains committed to enabling our global clients to speed drug development more efficiently, benefiting patients worldwide."

About WuXiUP^TM 

WuXiUP^TM is an intensified perfusion culture process developed as a next-generation biomanufacturing solution that provides high-yield, high-quality drug products while being highly flexible and cost-effective. Compared to traditional fed-batch and perfusion processes, WuXiUP^TM enables the manufacturing of diverse pharmaceutical proteins, including mAb, bispecific antibody, fusion protein, and other recombinant protein, with 5–20× higher productivity.

This performance advantage is particularly notable when scaling to 1,000–2,000 L using single-use bioreactors, where it achieves productivity levels comparable to those of traditional 10,000–20,000 L stainless steel bioreactors. The WuXiUP^TM platform has enabled one molecule to receive BLA approval and 11 others to receive IND approvals.

SOURCE WuXi Biologics

Candy Zhao，[email protected]