WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, dedicated to vaccine Contract Development and Manufacturing Organization (CDMO), announced that its drug substance facility (MFG23) located in Suzhou has received Good Manufacturing Practices (GMP) certification from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The facility is providing integrated manufacturing services for Instituto Butantan's dengue vaccine (Butantan-DV) production project.

GMP certification was granted following comprehensive on-site inspections of MFG23, a commercial drug substance manufacturing facility, as well as its QA, QC, MSAT, warehouse, and utilities. Previously, the drug product manufacturing facility (DP17) at the same site received ANVISA GMP certification for the dengue vaccine project in February 2026.

Jian Dong, CEO of WuXi Vaccines, commented, "The GMP certification of our DS facility, our second certification from ANVISA, represents a pivotal step in advancing our dengue vaccine project with Instituto Butantan and establishing a solid foundation to deliver on our shared commitment to expand access to high-quality dengue vaccines. Adhered to premier quality standards and powered by our integrated solutions and technologies, we remain committed to driving greater access to safe, effective, and affordable vaccines worldwide."

Based on the commercial manufacturing agreement with Instituto Butantan and Fundação Butantan, WuXi Vaccines will provide end-to-end services, including drug substance and drug product manufacturing and quality control for the 5-dose dengue vaccine. The partnership will rapidly scale up vaccine capacity, aiming to deliver millions of doses to shield Brazil's population from dengue. In November 2025, the single-dose Butantan-DV received ANVISA approval for use with individuals aged 12 to 59.