WuXi Biologics announced the successful completion of the first manufacturing run at its drug substance facility MFG7, paving the way for large-scale commercial manufacturing projects at this Ireland site.
The manufacturing run reached 16,000-liter scale by combining four 4,000-liter single-use bioreactors. This pioneering paradigm marks not only the first successful manufacturing run for the MFG7 facility, but also the largest manufacturing scale for WuXi Biologics to date. The Cost of Goods (COGS) from this run is comparable to that of a 16,000-liter traditional stainless-steel bioreactor, reinforcing the comparable cost seen in over 100 runs at 12,000-liter scale single-use bioreactors (6x2,000-liter in MFG2 and MFG5 facilities; 3x4,000-liter in MFG5 and MFG8 facilities) compared with a traditional 12,000-liter stainless steel bioreactor.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited to achieve this milestone for the Ireland facility. Once again it demonstrates that comparable COGS can be achieved by leveraging more ESG friendly single-use technologies. We look forward to supporting the development and manufacture of life-saving treatments for our global clients to benefit patients worldwide."
The Ireland site of WuXi Biologics received the Facility of the Year Award (FOYA) in the Operations category from ISPE in 2023. It took only nine months from the start of operations to receive the first GMP certificate from the Irish Health Products Regulatory Authority (HPRA). The Ireland site also attained ISO 50001 (Energy Management), ISO 14001 (Environmental Management System), and ISO 45001 (Occupational Health and Safety Management System) certifications in December 2023.
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