WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization (CRDMO), has announced a significant manufacturing milestone with the successful completion of its first commercial Process Performance Qualification (PPQ) campaign utilizing three 5,000L single-use bioreactors (SUBs) at its MFG20 facility in Hangzhou, China.
The achievement represents a breakthrough as Asia's first 5,000L drug substance scale-up line using single-use technology, demonstrating WuXi Biologics' advanced capabilities in applying single-use technology (SUT) for large-scale biopharmaceutical production.
Technological Innovations Drive Efficiency Gains
The company's proprietary process innovations have delivered remarkable results in the PPQ campaign. Protein production costs per gram were reduced by nearly 70%, while advanced mass transfer technology boosted protein yield by 20% per batch. These efficiency gains highlight the economic viability of single-use systems compared to traditional stainless-steel bioreactors.
Dr. Chris Chen, CEO of WuXi Biologics, emphasized the significance of this achievement: "The successful completion of the first commercial PPQ campaign of the 15,000-liter single-use bioreactors demonstrates our continued leadership in commercial biomanufacturing."
He noted that over the past six years, 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% production success rate over the past three years.
"Single-use technology manufacturing can attain costs of goods (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," Dr. Chen added.
Expanded Manufacturing Capacity
The three 5,000L single-use bioreactors, commissioned in 2024, represent WuXi Biologics' largest operational SUBs to date. The systems achieved successful commercial-scale engineering runs within the same year of installation.
When integrated with the four existing 2,000L single-use production lines at the same facility, the site's total capacity has increased substantially from 8,000L to 23,000L. This expansion enhances the company's ability to offer flexible scale-up solutions to meet varying client needs.
Operational Excellence and Environmental Commitment
The MFG20 facility has demonstrated operational excellence with a 100% PPQ success rate across multiple programs. The facility has also received ISO 14001 (Environmental Management System) and ISO 45001 (Occupational Health and Safety Management System) certifications, underscoring WuXi Biologics' commitment to sustainable and safe manufacturing practices.
Furthermore, the MFG20 facility's 4 x 2,000L SUBs work in synergy with the vial filling and pre-filled syringe units at the co-located DP9 drug product facility, enabling more efficient end-to-end commercial-scale operations.
Strategic Importance for Global Biopharmaceutical Manufacturing
This milestone reinforces WuXi Biologics' position at the forefront of advanced manufacturing solutions in the global biopharmaceutical industry. With over 12,000 skilled employees across China, the United States, Ireland, Germany, and Singapore, the company continues to expand its capabilities to support its growing portfolio of client projects.
As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects). The successful implementation of large-scale single-use technology at the Hangzhou site further strengthens the company's ability to deliver cost-effective and environmentally sustainable manufacturing solutions for biologics from concept to commercialization.
