WuXi Vaccines Receives GMP Certificate from HPRA

WuXi Vaccines, a global vaccines contract development and manufacturing organization (CDMO), 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 an 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 with a global pharmaceutical company to enable the manufacturing of its commercial vaccine products.

“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,” said 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.

WuXi Vaccines is a joint venture between WuXi Biologics and Shanghai Hile Bio-Technology.