WuXi Biologics Successfully Completes First 1,6000L Manufacturing Run in Ireland

Rhea-AI Summary

WuXi Biologics successfully completes the first manufacturing run at its drug substance facility MFG7 in Ireland, achieving the largest manufacturing scale to date by combining four 4,000-liter single-use bioreactors. 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. The Ireland site also received the Facility of the Year Award (FOYA) in the Operations category from ISPE in 2023 and attained ISO certifications for energy management, environmental management, and occupational health and safety management.

-  First manufacturing run successful for MFG7 facility at the Ireland site
-  Largest manufacturing scale to date achieved by combining four 4,000-liter single-use bioreactors

DUNDALK, Ireland, Jan. 31, 2024 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has successfully completed 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.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2023, WuXi Biologics is supporting 698 integrated client projects, including 24 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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SOURCE WuXi Biologics

FAQ

What is the significance of WuXi Biologics' successful manufacturing run at its MFG7 facility in Ireland?

The successful manufacturing run at the MFG7 facility in Ireland marks the largest manufacturing scale to date for WuXi Biologics, achieved by combining four 4,000-liter single-use bioreactors.

What are the certifications attained by WuXi Biologics' Ireland site?

The Ireland site of WuXi Biologics attained ISO 50001 for Energy Management, ISO 14001 for Environmental Management System, and ISO 45001 for Occupational Health and Safety Management System in December 2023.

What award did the Ireland site of WuXi Biologics receive in 2023?

The Ireland site received the Facility of the Year Award (FOYA) in the Operations category from ISPE in 2023.