WuXi Biologics a global Contract Research, Development and Manufacturing Organisation (CRDMO) has 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 accomplishment not only marks a significant breakthrough as Asia's first 5,000L drug substance scale-up line utilising SUBs, but also demonstrates the company's industry-leading capabilities in single-use technology (SUT) application for large-scale production.

According to the company, their innovative process technologies have been instrumental in achieving remarkable PPQ outcomes: Protein production costs per gram were reduced by nearly 70 percent, while advanced mass transfer technology delivered a 20 percent 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.

Dr. Chris Chen, CEO of WuXi Biologics, said, "The successful completion of the first commercial PPQ campaign of the 15,000-liter single-use bioreactors demonstrates our continued leadership in commercial biomanufacturing. Over the past six years, by leveraging continuous process innovation, the company has applied SUT manufacturing in over 300 batches of scaled production ranging from 4,000L to 16,000L across multiple facilities, achieving a 99 percent production success rate over the past three years."

"Single-use technology manufacturing can attain COGs comparable to stainless-steel systems – while being the more eco-friendly approach – and it provides clients with greater flexibility and a wider range of options for patients worldwide. Moving forward, we remain committed to exploring and applying cutting-edge technologies to empower partners in delivering high-quality innovative therapies to patients worldwide," added Dr. Chen.

The MFG20 facility's operational excellence is underlined by its 100 percent 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 synergise 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.