- WuXi Vaccines has received GMP certification from Agência Nacional de Vigilância Sanitária for its DP17 fill and finish facility in Suzhou.
- The certification supports integrated manufacturing services for Instituto Butantan’s single-dose dengue vaccine, Butantan-DV.
WuXi Vaccines, a vaccine-focused CDMO and wholly owned subsidiary of WuXi Biologics, has received Good Manufacturing Practices (GMP) certification from Agência Nacional de Vigilância Sanitária (ANVISA) for its DP17 fill and finish facility in Suzhou. The certification follows comprehensive on-site inspections of the commercial facility, which includes liquid and lyophilized capabilities, as well as quality assurance, quality control, warehouse, and utilities operations.
The Suzhou facility is providing integrated manufacturing services for Instituto Butantan’s dengue vaccine production project. WuXi Vaccines previously passed the EU Qualified Person audit at the site in 2024.
Under a commercial manufacturing agreement with Instituto Butantan and Fundação Butantan, WuXi Vaccines will deliver end-to-end services, including drug substance and drug product manufacturing and quality control. The partnership aims to scale up vaccine capacity to support dengue prevention efforts in Brazil, with a goal of delivering several million doses.
In November 2025, the single-dose Butantan-DV received ANVISA approval for use in individuals aged 12 to 59. Jian Dong, CEO of WuXi Vaccines, stated that the GMP certification marks the first regulatory milestone at the Suzhou site and reflects the company’s commitment to quality standards and integrated vaccine contract manufacturing services.
