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WuXi Biologics Completes Its First 16,000L Manufacturing Run in Ireland

Thursday, February 01, 2024

WuXi Biologics ("WuXi Bio") (2269.HK) has declared the successful completion of the inaugural manufacturing run at its drug substance facility, MFG7, situated in Ireland. This achievement stands as a significant milestone for the Contract Research, Development, and Manufacturing Organization (CRDMO) and sets the stage for large-scale commercial manufacturing projects at the site.

The manufacturing run at MFG7 reached a scale of 16,000 liters, achieved through the combination of four 4,000-liter single-use bioreactors. This groundbreaking endeavor not only represents the facility's first successful manufacturing run but also stands as the largest manufacturing scale ever attained by WuXi Biologics. The Cost of Goods (COGS) for this run is on par with that of a 16,000-liter traditional stainless-steel bioreactor. This reaffirms the comparable cost observed in over 100 runs at a 12,000-liter scale using single-use bioreactors in other facilities (6x2,000 liters in MFG2 and MFG5; 3x4,000 liters in MFG5 and MFG8) when compared to a traditional 12,000-liter stainless steel bioreactor.

WuXi Biologics, expressed excitement about achieving this milestone for the Ireland facility. He emphasized that the success demonstrates the feasibility of attaining comparable COGS through the use of environmentally friendly single-use technologies. The company looks forward to continuing its support for the development and manufacture of life-saving treatments for global clients, ultimately benefiting patients worldwide.

The Ireland site of WuXi Biologics was honored with the Facility of the Year Award (FOYA) in the Operations category by ISPE in 2023. Remarkably, it took only nine months from the commencement of operations to receive the first GMP certificate from the Irish Health Products Regulatory Authority (HPRA). Additionally, the Ireland site secured ISO 50001 (Energy Management), ISO 14001 (Environmental Management System), and ISO 45001 (Occupational Health and Safety Management System) certifications in December 2023.

 

Source: prnewswire.com

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