- The Dundalk site completed two 16,000-liter PPQ runs with a 100% success rate.
- HPRA granted GMP approval after an October 2024 inspection.
- The site employs over 760 staff and began operations in March 2022.
- The facility holds ISO certifications in energy, environmental, and occupational safety management.
Site Achievements
WuXi Biologics' Dundalk site in Ireland has completed two successful 16,000-liter Process Performance Qualification (PPQ) runs at its MFG7 drug substance suite. The site achieved a 100% success rate in these runs, which utilize four 4,000-liter single-use bioreactors, marking one of the largest cell culture processes using single-use technology globally.
Regulatory Approvals
The Irish Health Products Regulatory Authority (HPRA) granted Good Manufacturing Practice (GMP) approval to all three manufacturing facilities at the Dundalk site. This approval followed a comprehensive on-site inspection in October 2024, assessing GMP oversight across data, processes, personnel, manufacturing, storage, and analytical areas.
Operational Timeline
Operational since March 2022, the Dundalk site has rapidly established itself as a leader in advanced biomanufacturing. The facility employs over 760 skilled workers and features three advanced drug substance manufacturing suites, including a 6,000L perfusion suite and a 48,000L fed-batch suite.
Sustainability and Certifications
The Dundalk site is committed to sustainability, holding ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational safety (ISO 45001). These certifications highlight the site's dedication to environmental responsibility and industry advancement through innovation.
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