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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