WuXi Biologics secures first EMA approval for commercial biologic from its Ireland facility showcasing 48000L fed-batch capacity and 16000L single-use bioreactor runs. A win for global supply resilience & ESG-focused bioproduction.
Dundalk Site Emerges as Key Global Hub with Industry-Leading 48,000L Biomanufacturing Capacity
Dundalk, Ireland – In a landmark development for global biomanufacturing WuXi Biologics has secured European Medicines Agency (EMA) approval for the first commercial biologic produced at its Dundalk, Ireland facility—marking a significant validation of the company’s Global Dual Sourcing Strategy. The achievement follows the site’s 2023 GMP authorization and demonstrates WuXi’s ability to deliver regulatory-compliant large-scale biologics production across multiple geographies.
Key Highlights of the Milestone
🌍 Strategic Global Footprint Expansion
✔ First EMA-approved commercial product from Irish facility
✔ Dual Sourcing Success: Same product already approved at multiple FDA/EMA-qualified sites since 2023
✔ Scalability: Site features 6,000L perfusion & 48,000L fed-batch capacity—among largest single-use bioreactor runs globally
🏭 Cutting-Edge Manufacturing Capabilities
✅ Unprecedented Scale: Achieved 16,000L run via 4×4,000L single-use bioreactors (industry benchmark)
✅ 100% PPQ Success Rate: Flawless large-scale Process Performance Qualification runs
✅ ESG Leadership: Demonstrated cost-parity with traditional stainless steel while reducing environmental impact
💡 Leadership Insight
Dr. Chris Chen, CEO, WuXi Biologics:
“This approval proves our Global Dual Sourcing Strategy delivers robust, flexible manufacturing across continents while maintaining perfect regulatory compliance. Our Dundalk site is now a pillar of WuXi’s network, combining scale with sustainability through advanced single-use tech.”
Why This Approval Matters?
🔹 Supply Chain Resilience: Mitigates geopolitical risks via multi-continent production
🔹 Sustainability Benchmark: Single-use bioreactors reduce water/energy use vs stainless steel
🔹 Commercial Readiness: Positions WuXi for global Big Pharma partnerships
🔹 Irish Biopharma Boost: Strengthens Europe’s biologics manufacturing ecosystem
Concurrent Expansion: WuXi’s Microbial Therapy Push
- New China facility underway for next-gen microbial therapies
- Expands capabilities beyond mammalian cell culture
- Aligns with growing demand for novel modalities (e.g., live biotherapeutics, mRNA)
