WuXi Biologics Completes First Commercial PPQ Campaign at 15,000L Production Line in Hangzhou Site

Rhea-AI Summary

WuXi Biologics (2269.HK) has successfully completed its first commercial Process Performance Qualification (PPQ) campaign at its MFG20 facility in Hangzhou, featuring Asia's first three 5,000L single-use bioreactors (SUBs). The company achieved significant breakthroughs in manufacturing efficiency:

- Reduced protein production costs by nearly 70%
- Increased protein yield by 20% per batch through advanced mass transfer technology
- Expanded total site capacity from 8,000L to 23,000L by integrating with existing 2,000L production lines

The facility demonstrates operational excellence with a 100% PPQ success rate and holds ISO 14001 and ISO 45001 certifications. The company has implemented single-use technology (SUT) manufacturing in over 300 batches across multiple facilities, achieving a 99% production success rate over the past three years.

Positive

• 70% reduction in protein production costs
• 20% increase in protein yield per batch
• Significant capacity expansion from 8,000L to 23,000L
• 99% production success rate over past three years
• 100% PPQ success rate at MFG20 facility

Negative

• None.

-          The campaign marks the successful commercial-scale PPQ completion of Asia's first 3 X 5,000L single-use bioreactors
-          Proprietary process innovation reduces protein cost by nearly 70% while boosting yield 20%
-          As the company's largest operational single-use bioreactor to date, the system triples total site capacity to 23,000L, enabling flexible scale-up solutions

HANGZHOU, China, April 18, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), 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 utilizing SUBs, but also demonstrates the company's industry-leading 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.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "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% 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."

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.

About WuXi Biologics

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

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

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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SOURCE WuXi Biologics

FAQ

What efficiency improvements did WuXi Biologics (WXXWY) achieve with its new 15,000L bioreactor system?

WuXi Biologics achieved a 70% reduction in protein production costs and a 20% increase in protein yield per batch through advanced mass transfer technology.

How much did the Hangzhou facility's production capacity increase after adding the new bioreactors?

The total production capacity at the Hangzhou site increased from 8,000L to 23,000L after integrating three 5,000L single-use bioreactors with existing 2,000L production lines.

What is the success rate of WuXi Biologics' single-use technology manufacturing?

WuXi Biologics has achieved a 99% production success rate over the past three years across 300+ batches of scaled production ranging from 4,000L to 16,000L.

What certifications does WuXi Biologics' MFG20 facility hold?

The MFG20 facility holds ISO 14001 (Environmental Management System) and ISO 45001 (Occupational Health and Safety Management System) certifications.