SuzhouMay 26, 2026 /PRNewswire/ — WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics specializing in vaccine contract development and manufacturing (CDMO) services, today announced that its biologics drug substance manufacturing facility (MFG23) at the Suzhou site has received Good Manufacturing Practice (GMP) certification from the Brazilian Health Regulatory Agency (ANVISA) for the production of the Butantan-DV dengue vaccine developed by the Butantan Institute.
This GMP certification was based on a comprehensive on-site inspection by ANVISA of MFG23, covering quality assurance (QA), quality control (QC), manufacturing science and technology (MSAT), warehouses, and utilities. Previously, the biologics drug product filling facility (DP17) at the same site received GMP certification from ANVISA for the dengue vaccine production project in February 2026.
Mr. Dong Jian, CEO of WuXi Vaccines, stated: “This GMP certification for the drug substance facility marks the second time WuXi Vaccines has received certification from ANVISA and represents a significant milestone in advancing the dengue vaccine project with the Butantan Institute. It also lays a solid foundation for fulfilling our mutual commitment to improving access to high-quality dengue vaccines. Upholding the highest quality standards and leveraging integrated solutions and technology platforms, WuXi Vaccines will continue to empower global public health by enhancing the accessibility of safe, effective, and affordable vaccines.”
Under a commercial production agreement signed with the Butantan Institute and the Butantan Foundation, WuXi Vaccines will provide end-to-end services for the drug substance and drug product manufacturing, as well as quality control, of a five-dose dengue vaccine for the Butantan Institute. This aims to rapidly increase vaccine capacity and build a defense against dengue for the Brazilian population. The collaboration is expected to supply tens of millions of doses of the dengue vaccine to the Brazilian market. A single-dose version of Butantan-DV received ANVISA approval in November 2025 for individuals aged 12 to 59.
About WuXi Vaccines
WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, focuses on providing contract development and manufacturing (CDMO) services for human vaccines and prophylactic antibodies. Through its integrated capabilities and technology platforms, the company empowers partners to accelerate the development and commercialization of vaccines and prophylactic antibodies. Whether for prophylactic monoclonal antibodies, recombinant protein vaccines, viral vaccines, viral vector vaccines, virus-like particle (VLP) vaccines, outer membrane vesicle (OMV) vaccines, nucleic acid vaccines, or conjugate vaccines, WuXi Vaccines leverages deep technical expertise, extensive regulatory knowledge, a first-class quality system, advanced CMC development capabilities, diverse technology platforms (e.g., mammalian cells, microbial systems, viruses, protein conjugation technologies), and ample GMP capacity to provide end-to-end services from development to large-scale commercial production. It delivers vaccine and prophylactic antibody products to global markets, safeguarding public health. For more information, please visit https://wuxivaccines.com.