WuXi Biologics secures EMA approval for commercial manufacturing in Ireland

WuXi Biologics secures EMA approval for commercial manufacturing in Ireland

WuXi Biologics’ Dundalk facility has received European Medicines Agency approval to begin commercial production of a global client’s innovative biologic. The site, equipped with advanced 6,000L perfusion and 48,000L fed-batch capacity, has achieved 100 percent success across multiple large-scale process runs, including one of the largest single-use cell culture processes worldwide. The approval reinforces WuXi’s global dual sourcing strategy, combining regulatory consistency with ESG-focused single-use technologies.

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