#Ireland #WuXi Biologics #Dundalk #GMP Approval

WuXi Biologics Celebrates Major Achievements at Its Dundalk Facility

WuXi Biologics (stock code: 2269.HK), a prominent global Contract Research, Development, and Manufacturing Organization (CRDMO), has recently made impressive strides at its newly developed Dundalk site in Ireland. The facility has successfully conducted multiple 16,000-liter Process Performance Qualification (PPQ) runs, showcasing its advanced manufacturing capabilities.

The completion of these runs signifies a major accomplishment for the site, which has now tallied two successful PPQ runs at 100% success rate. This noteworthy achievement emphasizes WuXi Biologics' commitment to providing top-tier biomanufacturing solutions as part of its global operations. Furthermore, all three manufacturing facilities within the site have obtained Good Manufacturing Practice (GMP) authorization from the Irish Health Products Regulatory Authority (HPRA) simultaneously, further enhancing their credibility in the biomanufacturing landscape.

The technological advancements at the Dundalk facility are noteworthy, particularly with its utilization of four 4,000-liter single-use bioreactors. This innovative combination enables the facility to scale up to 16,000 liters, marking it as one of the largest cell culture processes utilizing single-use technology globally. This method not only enhances operational efficiency but also aligns with sustainability goals, showing comparable Cost of Goods (COGS) to those achieved with traditional stainless steel bioreactors, which can reach sizes of up to 20,000 liters.

The GMP authorization provided by the HPRA came after a thorough onsite inspection conducted in October 2024, during which all aspects of data handling, personnel, manufacturing processes, and storage were meticulously evaluated. The approval allows WuXi Biologics to extend its services to meet the pressing demands of patients globally, reinforcing their dedication to maintaining high-quality standards that comply with international regulations.

Dr. Chris Chen, the CEO of WuXi Biologics, stated, "These achievements exemplify our site's exceptional speed, agility, and execution capabilities, while underscoring our firm commitment to quality, innovation, and sustainability. By reaching these milestones, we are reinforcing our global manufacturing network and promoting our mission to provide life-saving therapies to patients around the world."

Since its operational launch in March 2022, the Ireland site has swiftly risen to prominence in advanced biomanufacturing with over 760 highly skilled employees. The facility combines innovative design, an emphasis on sustainability, and scalability, making it a frontrunner in the industry. In recognition of its achievements, the site received the distinguished International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Award (FOYA) in 2023, further validating its position as a leader in drug substance manufacturing.

Besides the impressive manufacturing capabilities, the facility is also devoted to sustainable practices, boasting ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational health and safety (ISO 45001). These achievements reflect WuXi Biologics' unwavering commitment to driving the industry forward through both innovation and environmental stewardship.

About WuXi Biologics

WuXi Biologics is recognized globally as a leading CRDMO, offering comprehensive solutions that empower partners to discover, develop, and manufacture biologics from concept to commercialization to benefit patients worldwide. With a workforce of over 12,000 skilled professionals across China, the United States, Ireland, Germany, and Singapore, the company utilizes advanced technologies to deliver efficient and cost-effective biologics solutions. As of mid-2024, WuXi Biologics is involved in 742 integrated client projects, including 16 in commercial manufacturing, emphasizing its significant role in the global biopharmaceutical sector.

In addition, WuXi Biologics places strong emphasis on Environmental, Social, and Governance (ESG) responsibilities as a core part of its business framework, aspiring to lead in ESG practices within the CRDMO sector. With state-of-the-art facilities employing next-generation biomanufacturing technologies and clean energy sources, the company has established an ESG committee devoted to implementing comprehensive strategies enhancing its sustainability commitment.

For further details about WuXi Biologics, visit www.wuxibiologics.com.