WuXi Vaccines Achieves ANVISA GMP Certification to Combat Dengue in Brazil
WuXi Vaccines' Recent Achievement in Vaccine Production
Introduction
In a significant advancement for public health and dengue prevention, WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, has received Good Manufacturing Practices (GMP) certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for its drug substance facility, MFG23, located in Suzhou, China. This certification marks a vital step toward improving the manufacturing capabilities for the dengue vaccine being developed in partnership with Instituto Butantan.
Details of the Certification
The GMP certification was awarded following detailed on-site inspections that evaluated various aspects of the facility, including quality assurance (QA), quality control (QC), manufacturing science and technology (MSAT), as well as utilities and warehousing. This achievement builds on WuXi Vaccines' prior GMP certification for its drug product manufacturing facility (DP17) in February 2026, which also pertains to the same dengue vaccine project.
Importance of the Certification
Jian Dong, the CEO of WuXi Vaccines, emphasized the significance of obtaining the GMP certification, stating that it reinforces their commitment to expanding access to high-quality dengue vaccines.
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