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WuXi Biologics Achieves Groundbreaking PPQ Success in Hangzhou

WuXi Biologics, a prominent global leader in Contract Research, Development and Manufacturing Organization (CRDMO), recently announced a significant milestone in biomanufacturing with the completion of its first commercial Process Performance Qualification (PPQ) campaign. This milestone took place in the Hangzhou facility, where the company recognizes a major advancement in its production capabilities through the implementation of three state-of-the-art 5,000-liter single-use bioreactors (SUBs).

A Historic First for Asia

The successful PPQ campaign signifies the operationalization of Asia's first 5,000L drug substance scale-up line utilizing single-use technology. This innovative achievement not only showcases WuXi's industry-leading expertise in single-use technology application but also positions the company at the forefront of advanced biomanufacturing solutions.

The integration of three 5,000L bioreactors effectively increases the site’s total production capacity from 8,000 liters to an impressive 23,000 liters. This enhanced capacity facilitates flexible scale-up solutions, allowing WuXi Biologics to better meet the growing demands of its clients in the biopharmaceutical sector.

Cost and Yield Improvements

WuXi Biologics' proprietary process technologies have optimized production efficiency, leading to a reduction in protein production costs by nearly 70%. This significant decrease translates to a more economically feasible option for producing biologics at commercial scales. Additionally, the deployment of advanced mass transfer technology has resulted in a 20% increase in protein yield per batch, highlighting the effectiveness and reliability of the newly established production equipment.

Dr. Chris Chen, CEO of WuXi Biologics, commented on the achievement, stating, "The successful completion of the first commercial PPQ campaign demonstrates our continued leadership in commercial biomanufacturing. Over the past six years, by leveraging continuous process innovation, we have achieved a staggering 99% production success rate, addressing more than 300 batches of scaled production ranging from 4,000 liters to 16,000 liters across various facilities."

Commitment to Sustainability

Emphasizing the importance of sustainability in modern manufacturing, Dr. Chen further explained, "Our single-use technology not only matches the cost of goods sold (COGs) of traditional stainless-steel systems but also promotes a greener approach to production. We are dedicated to using cutting-edge technologies that empower our partners to deliver high-quality, innovative therapies to patients worldwide."

The Hangzhou facility also holds an impressive track record of a 100% success rate in PPQ across multiple programs, coupled with certified adherence to international standards such as ISO 14001 and ISO 45001. The synergy between the facility’s SUBs and the associated drug product processing units enhances operational efficiency, ensuring high levels of productivity in commercial-scale operations.

WuXi’s Global Reach and Future Prospects

Founded to enable partners to discover, develop, and manufacture biologics from concept to commercialization, WuXi Biologics supports over 817 integrated client projects. Recently, it has also been recognized for its commitment to sustainability, focusing on delivering environmentally conscious solutions through its Green CRDMO initiative. The company aims to promote positive social and environmental impacts while fostering responsible practices across its value chain.

In conclusion, WuXi Biologics' completion of its first commercial PPQ campaign marks a substantial advancement in biomanufacturing capabilities within the region and globally. With scalable production solutions and a commitment to innovation, WuXi Biologics continues to lead the way in advanced biologics manufacturing, improving access to critical therapies for patients around the world.