WuXi Biologics Completes First Commercial PPQ at Hangzhou Site

• WuXi Biologics has completed its first commercial Process Performance Qualification (PPQ) campaign for a 15,000L single-use bioreactor system at its Hangzhou site.

• The upgrade enhances production capacity and reduces protein production costs by nearly 70%.

WuXi Biologics has completed its first commercial Process Performance Qualification (PPQ) campaign for three 5,000L single-use bioreactors (SUBs) at its MFG20 facility in Hangzhou, marking a milestone in large-scale biologics manufacturing in Asia.

This development makes the MFG20 site the first in Asia to operate a 15,000L single-use drug substance scale-up line. The installation raises the facility’s total production capacity from 8,000L to 23,000L, when combined with its four existing 2,000L SUBs. The PPQ campaign was executed within the same year the bioreactors were commissioned in 2024.

The project achieved notable cost and yield benefits. Protein production costs per gram were cut by nearly 70%, and mass transfer improvements led to a 20% increase in yield per batch. According to the company, its single-use manufacturing systems have now delivered more than 300 production batches at scales from 4,000L to 16,000L, with a 99% success rate over the past three years.

Dr. Chris Chen, CEO of WuXi Biologics, stated, “The successful completion of the first commercial PPQ campaign of the 15,000-liter single-use bioreactors demonstrates our continued leadership in commercial biomanufacturing.”

The MFG20 facility is also certified under ISO 14001 and ISO 45001 standards and integrates closely with the DP9 drug product unit, which includes vial filling and pre-filled syringe capabilities.