WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, dedicated to vaccine Contract Development and Manufacturing Organization (CDMO), announced that it has received Good Manufacturing Practices (GMP) certification for its fill and finish facility (DP17) in Suzhou 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.

Following comprehensive on-site inspections of DP17, a commercial fill and finish facility with both liquid and lyo capabilities, as well as QA, QC, warehouse and utilities, the GMP certification was granted. The Suzhou site previously passed the EU Qualified Person (QP) audit in 2024.

Jian Dong, CEO of WuXi Vaccines, commented, "We are very excited to achieve our first regulatory milestone at our Suzhou site. It not only validates the excellence of our world-class quality system, but also underscores our shared commitment with Instituto Butantan to enhancing access to high-quality dengue vaccines. Adhering to premier quality standards and providing end-to-end services with our integrated technologies, we remain committed to enabling greater vaccine accessibility and affordability for the global public health community."

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. The partnership will rapidly scale up vaccine capacity to help protect Brazil's population from dengue, with a goal to deliver several millions of doses. In November 2025, the single-dose Butantan-DV received ANVISA approval for use with individuals aged 12 to 59.