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Dundalk, Ireland site is recognized for its regulatory compliance and product safety.
WuXi Biologics, a contract research, development, and manufacturing organization (CRDMO), has been awarded a 2023 Facility of the Year Award (FOYA) in the Operations category by the International Society for Pharmaceutical Engineering (ISPE). The CRDMO was recognized for using innovative solutions while complying with regulatory requirements, overcoming unknown barriers, and upholding project success and product safety at its manufacturing facility in Dundalk, Ireland.
The 467,500-square-foot plant features two manufacturing areas that use 6x1KL single-use bioreactors for perfusion and 12x4KL single-use bioreactors for fed-batch. Construction of the site began in December 2018, while operations commenced in December 2021. In nine months, the facility was able to receive its first good manufacturing practice (GMP) certificate from the Irish Health Products Regulatory Authority (HPRA).
Following WuXi Biologics’ environmental, social, and governance (ESG) strategy, sustainable concepts were implemented into the site’s construction and operations, including reducing energy use and recycling resources. Currently, 100 percent of power supply comes from renewable energy at the Ireland site.
“This recognition by ISPE is a testament to our team’s dedication and relentless pursuit of excellence. It also signifies success for our clients, partners, and local community, and, ultimately, for the patients who rely on the life-saving biologics manufactured at our Ireland site,” says Brendan McGrath, VP and head of WuXi Biologics’ Ireland site.