WuXi Biologics announced the successful completion of the first commercial project Process Performance Qualification (PPQ) campaign for its three sets of 5,000L single-use bioreactors (SUBs) in the second drug substance line of its MFG20 facility at the Hangzhou site. The achievement not only marks a significant breakthrough as Asia's first 5,000L drug substance scale-up line utilizing SUBs, but also demonstrates the company's capabilities in single-use technology (SUT) application for large-scale production, reaffirming its position at the forefront of advanced manufacturing solutions. WuXi Biologics' innovative process technologies have been instrumental in achieving remarkable PPQ outcomes: Protein production costs per gram were reduced by nearly 70%, while advanced mass transfer technology delivered a 20% increase in protein yield per batch.
In 2024, the company commissioned three 5,000L single- use bioreactors, its largest operational SUBs to date, and the systems achieved successful commercial-scales engineering run within the same year. Integrated with four existing 2,000L single-use technology production lines at the same facility, the site's total capacity is elevated from 8,000L to 23,000L. The MFG20 facility's operational excellence is underscored by its 100% PPQ success rate across multiple programs and ISO 14001 (Environmental Management System) and ISO 45001 (Occupational Health and Safety Management System) certifications.
In addition, MFG20's 4 x 2,000L SUBs synergize with the vial filling and pre-filled syringe units at the co-located DP9 drug product facility, propelling commercial-scale operations with increased efficiency and productivity.
