WuXi Vaccines Received First GMP Certificate of QC Potency Lab from Ireland Health Products Regulatory Authority

Rhea-AI Summary

WuXi Vaccines has received its first GMP certificate from the Ireland HPRA for its QC potency lab, a key milestone for manufacturing commercial vaccine products at its Dundalk facility. This certification supports a 20-year contract valued at approximately $3 billion USD with a top global pharmaceutical company. The QC lab has been operational since July 2020 and reflects WuXi's commitment to addressing global vaccine manufacturing challenges, especially in light of increased demand due to the COVID-19 pandemic.

Positive

• Received first GMP certificate from Ireland HPRA for QC potency lab.
• Facilitates future manufacturing of commercial vaccine products at Dundalk.
• Supports a substantial 20-year, $3 billion USD contract with a global pharmaceutical company.
• Demonstrates commitment to enhancing global vaccine accessibility and innovation.

Negative

• None.

- The first GMP certificate that WuXi Vaccines has received from the regulatory agency

- A critical step for WuXi Vaccines to enable the manufacturing of commercial vaccine products in its Dundalk facility and supplying the global market for a top-10 pharmaceutical company

DUNDALK, Ireland, July 12, 2022 /PRNewswire/ -- WuXi Vaccines, a global leading vaccines Contract Development and Manufacturing Organization (CDMO), announced that it has received the GMP certificate from Ireland Health Products Regulatory Authority (HPRA) for its QC potency lab in Dundalk, Ireland. As the first GMP certificate, it marks a very important milestone for WuXi Vaccines since weather-tight construction of the main building was finished in March 2021.

The inspectors from HPRA evaluated WuXi Vaccines' QC potency lab during a three-day inspection, including its quality system, facility, equipment and quality control. The QC potency lab became operational at WuXi Vaccines' Ireland site in July 2020 as part of the company's vaccine manufacturing facility. WuXi Vaccines is currently under a 20-year contract valued at approximately $3 billion USD with a global pharmaceutical company to enable the manufacturing of its commercial vaccine products. The QC potency lab which was built and qualified as a modular facility is named as the winner of "Large Project of the Year" at the 2020 Pharma Industry awards in Ireland. 

"The first GMP certificate of QC potency lab demonstrates WuXi Vaccines' commitment to enabling our partners to pursue vaccine innovation and bring more new vaccine products to market," commented Jian Dong, CEO of WuXi Vaccines. "Vaccines face great manufacturing capacity shortages globally due to the process complexity, extensive analytic testing and rigorous regulatory standards, in particular with the increased demand brought by the COVID-19 pandemic. To enable global partners to tackle these challenges is our unwavering pursuit. We're proud to be engaging with the global health community to enhance the accessibility and affordability of high-quality vaccines to benefit the well-being of people worldwide."

WuXi Vaccines currently provides contract development and manufacturing services for multiple global partners, covering attenuated virus vaccines, adenovirus vector vaccines, VLP vaccines, recombinant protein vaccines, and mRNA vaccines. With its strong manufacturing track record and premier-quality supply chain, WuXi Vaccines has delivered hundreds of millions of COVID-19 vaccine doses for its partners to help people fight COVID-19 in over 180 countries.

About WuXi Vaccines

WuXi Vaccines is a joint venture between WuXi Biologics (Stock Code: 2269.HK) and Shanghai Hile Bio-Technology (Stock Code: 603718.SH). Through its world-class integrated platforms, WuXi Vaccines offers end-to-end solutions for global partners to discover, develop and manufacture vaccines (including cancer vaccines) from concept to commercial manufacturing. WuXi Vaccines signed a 20-year vaccine manufacturing contract valued at approximately $3 billion USD with a global pharmaceutical company. To implement this landmark agreement, WuXi Vaccines is building a vaccine manufacturing facility in Dundalk, Ireland, where it has completed weather-tight construction of the site's main building and begun operations in a newly built QC potency lab. For more information, please visit www.wuxibiologics.com/wuxi-vaccines.

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SOURCE WuXi Biologics

FAQ

What is the significance of the GMP certificate received by WuXi Vaccines?

The GMP certificate allows WuXi Vaccines to manufacture commercial vaccine products at its Dundalk facility, enabling it to fulfill a 20-year contract with a top pharmaceutical company.

What is the value of the contract WuXi Vaccines has secured?

WuXi Vaccines has secured a contract valued at approximately $3 billion USD for vaccine manufacturing.

When did WuXi Vaccines' QC potency lab become operational?

The QC potency lab at WuXi Vaccines became operational in July 2020.

How does WuXi Vaccines contribute to global vaccine manufacturing?

WuXi Vaccines aims to address manufacturing capacity shortages and enhance vaccine accessibility, especially in the wake of COVID-19.

How many vaccine doses has WuXi Vaccines delivered?

WuXi Vaccines has delivered hundreds of millions of COVID-19 vaccine doses to over 180 countries.