WuXi Biologics completed the first commercial project Process Performance Qualification (PPQ) campaign for its three sets of 5,000 L single-use bioreactors (SUBs) in the second drug substance line of its MFG20 facility at the Hangzhou site in China.
The accomplishment not only marks a “significant breakthrough” as Asia’s first 5,000 L drug substance scale-up line utilizing SUBs, but also demonstrates the company’s capabilities in single-use technology (SUT) application for large-scale production, said Chris Chen, PhD, CEO of WuXi Biologics.
According to Chen, WuXi Biologics’ process technologies have been able to achieve demonstrable 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 5,000 L single-use bioreactors, its largest operational SUBs to date, and the systems achieved a commercial-scale engineering run within the same year. Integrated with four existing 2,000 L single-use technology production lines at the same facility, the site’s total capacity is elevated from 8,000 L to 23,000 L, added Chen.
“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 4,000 L to 16,000 L across multiple facilities, achieving a 99% production success rate over the past three years,” he continued. “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.”