#Ireland #Biomanufacturing #WuXi Biologics #GMP Certification #Dundalk

WuXi Biologics Celebrates Key Achievements at its Ireland Facility

WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization (CRDMO), has recently announced significant accomplishments at its state-of-the-art facility located in Dundalk, Ireland. With the successful completion of multiple 16,000-liter Process Performance Qualification (PPQ) runs, the site is now poised to make a substantial impact in the biomanufacturing sector.

Major Milestones

The Dundalk facility achieved remarkable results by conducting two successful PPQ runs, boasting an impressive 100% success rate. This feat not only emphasizes the facility's operational excellence but also highlights the efficiency of disposable manufacturing techniques. By utilizing four 4,000-liter single-use bioreactors, WuXi Biologics has achieved one of the largest cell culture processes using this innovative technology, setting a new benchmark in the industry.

Simultaneously, the facility has secured Good Manufacturing Practice (GMP) approval from the Irish Health Products Regulatory Authority (HPRA). This prestigious certification was granted following a thorough inspection that scrutinized all aspects of the manufacturing process, including data handling, personnel training, and quality controls.

Impact on Global Operations

These advancements reinforce WuXi Biologics' commitment to providing world-class biomanufacturing solutions. With the GMP approval, the company is now able to expand its services to meet the pressing needs of patients globally, reinforcing their mission to ensure compliance with international standards and regulations. To date, WuXi Biologics has successfully navigated approximately 40 regulatory inspections across the globe, culminating in 67 license approvals.

Dr. Chris Chen, the CEO of WuXi Biologics, expressed his enthusiasm regarding these achievements, stating, "These milestones reflect the incredible agility and operational expertise of our Ireland site while underlining our dedication to quality, innovation, and sustainability."

A Commitment to Sustainability

The Dundalk facility, operational since March 2022, has committed itself to sustainability and quality. With over 760 highly skilled employees, the site boasts award-winning design and operational practices, having recently received the International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Award (FOYA) in 2023. The facility includes three advanced manufacturing suites, with capabilities extending to 48,000 liters in fed-batch production.

Beyond just production, WuXi Biologics is dedicated to environmental sustainability. The site has obtained ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational safety (ISO 45001), demonstrating a holistic approach to best practices in social responsibility.

WuXi Biologics aims to utilize next-generation biomanufacturing technologies while prioritizing clean energy solutions. The establishment of a dedicated ESG committee, led by the CEO, signifies the organization's commitment to leading in environmental, social, and governance (ESG) strategies within the biologics sector.

About WuXi Biologics

Founded with the objective of providing end-to-end solutions for biologics development, WuXi Biologics is headquartered in Hong Kong (stock code 2269.HK). They support partners through all phases from discovery to commercialization. With over 12,000 employees across sites in China, the USA, Ireland, Germany, and Singapore, their commitment to excellence continues to empower patients around the world.

WuXi Biologics remains focused on addressing the unmet needs of the healthcare sector while advancing industry standards through innovative practices and sustainable efforts.