News

WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, dedicated to vaccine Contract Development and Manufacturing Organization (CDMO), announced today 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.

About WuXi Vaccines

WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, is a leading contract development and manufacturing organization (CDMO) that focuses on vaccine and preventive antibody’s development and manufacturing. It provides world-class, integrated development and manufacturing platforms to expedite partners’ vaccines and preventive antibodies to the clinical stage and the market, regardless of the modality (i.e., recombinant protein, viral, viral vectored, VLP, OMV, nucleic acid, conjugated vaccines). With its technical expertise, broad regulatory knowledge, premium quality system, advanced CMC development capabilities, multiple production platforms (cell culture, viral, microbial, polysaccharide and protein conjugation), and extensive GMP manufacturing capacities, WuXi Vaccines provides an end-to-end service – from vaccine development to large-scale commercial production and distribution. The company can enable global clients to deliver critical vaccines and preventive antibodies anywhere in the world, making it an essential partner in protecting public health. For more information about WuXi Vaccines, please visit: https://wuxivaccines.com.

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