– This campaign marks the successful commercial PPQ completion of the first 3 X 5,000L single-use bioreactors in Asia at a commercial scale.
– Proprietary process advancements have led to a nearly 70% reduction in protein costs and a 20% increase in yield.
– The system, the company’s largest single-use bioreactor in operation to date, triples the total site capacity to 23,000L, providing adaptable scale-up options.

HANGZHOU, China, April 18, 2025 — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the successful completion of the first commercial Process Performance Qualification (PPQ) campaign for its three 5,000L single-use bioreactor (SUB) sets. These are located in the second drug substance line of its MFG20 facility at the Hangzhou site. This achievement signifies a major breakthrough as Asia’s first 5,000L drug substance scale-up line using SUBs. It also highlights the company’s industry-leading capabilities in single-use technology (SUT) application for large-scale production, reinforcing its position as a leader in advanced manufacturing solutions.

WuXi Biologics’ innovative process technologies were key to the remarkable PPQ outcomes. The cost of protein production per gram was reduced by almost 70%, while advanced mass transfer technology resulted in a 20% increase in protein yield per batch. In 2024, the company put into service three 5,000L single-use bioreactors, its largest SUBs in operation, and the systems successfully completed commercial-scale engineering runs within the same year. Integrated with four existing 2,000L single-use technology production lines at the same facility, the site’s total capacity increases from 8,000L to 23,000L.

Dr. Chris Chen, CEO of WuXi Biologics, commented, “The successful completion of the first commercial PPQ campaign using the 15,000-liter single-use bioreactors highlights our ongoing leadership in commercial biomanufacturing. Over the past six years, through continuous process innovation, the company has implemented SUT manufacturing in over 300 scaled production batches ranging from 4,000L to 16,000L across various facilities, achieving a 99% production success rate over the past three years. Single-use technology manufacturing can achieve COGs comparable to stainless-steel systems, while being a more eco-friendly option. It also offers clients greater flexibility and a wider range of choices for patients globally. Going forward, we are dedicated to exploring and implementing cutting-edge technologies to enable partners to deliver high-quality, innovative therapies to patients worldwide.”

The MFG20 facility demonstrates operational excellence with a 100% PPQ success rate across multiple programs and ISO 14001 (Environmental Management System) and ISO 45001 (Occupational Health and Safety Management System) certifications. Additionally, MFG20’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, driving commercial-scale operations with improved efficiency and productivity.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) providing end-to-end solutions that enable partners to discover, develop, and manufacture biologics – from idea to commercialization – for the benefit of patients around the world.

With a workforce of over 12,000 skilled employees in China, the United States, Ireland, Germany, and Singapore, WuXi Biologics utilizes its technologies and expertise to offer customers efficient and cost-effective biologics discovery, development, and manufacturing solutions. As of December 31, 2024, WuXi Biologics supports 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).

WuXi Biologics considers sustainability crucial for long-term business growth. The company consistently promotes green technology innovations to provide advanced end-to-end Green CRDMO solutions for its global partners, while maintaining excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to create positive social and environmental impacts and promote responsible practices throughout the value chain.

For more information about WuXi Biologics, please visit: .

SOURCE WuXi Biologics

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