SUZHOU, China, May 26, 2026
WuXi Vaccines, a wholly owned subsidiary of WuXi Biologics specializing in vaccine Contract Development and Manufacturing Organization (CDMO) services, has announced that its drug substance manufacturing facility (MFG23) in Suzhou has officially received Good Manufacturing Practice (GMP) certification from Brazil’s health regulatory agency, ANVISA. The certification marks a major milestone for the company’s large-scale dengue vaccine manufacturing partnership with Instituto Butantan, one of Brazil’s leading biomedical research institutions, and significantly strengthens global efforts to improve access to high-quality dengue vaccines in regions heavily affected by mosquito-borne disease outbreaks.
The newly certified facility will support integrated drug substance manufacturing operations for Butantan-DV, Instituto Butantan’s dengue vaccine program, which is expected to play an important role in protecting millions of people across Brazil and other high-risk regions from dengue infections. The announcement further reinforces WuXi Vaccines’ growing position as a major global vaccine CDMO provider with advanced GMP manufacturing capabilities and strong international regulatory compliance standards.
ANVISA Certification Strengthens Global Vaccine Manufacturing
According to WuXi Vaccines, the GMP certification was granted following extensive on-site inspections conducted by ANVISA across multiple operational areas within the Suzhou manufacturing campus. Regulatory inspections covered the MFG23 commercial drug substance facility along with associated quality assurance (QA), quality control (QC), manufacturing science and technology (MSAT), warehouse operations, and critical utility systems.
This latest approval follows an earlier ANVISA GMP certification awarded in February 2026 to WuXi Vaccines’ drug product manufacturing facility (DP17) located at the same Suzhou site. Together, the two certifications establish a fully integrated manufacturing platform capable of supporting both drug substance and drug product production for the dengue vaccine program.
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Jian Dong, Chief Executive Officer of WuXi Vaccines, described the approval as a pivotal achievement in advancing the partnership with Instituto Butantan and expanding access to safe, effective, and affordable vaccines globally. He emphasized that the company remains committed to maintaining premier international quality standards while leveraging its integrated development and manufacturing technologies to accelerate vaccine production for public health needs worldwide.
Dengue Vaccine Partnership Targets Millions of Doses
Under the commercial manufacturing agreement signed with Instituto Butantan and Fundação Butantan, WuXi Vaccines will provide comprehensive end-to-end services for the dengue vaccine project, including drug substance production, drug product manufacturing, and quality control testing for the vaccine program.
The collaboration is designed to rapidly scale manufacturing capacity to deliver millions of dengue vaccine doses for Brazil’s public immunization efforts. Dengue fever remains one of the fastest-growing mosquito-borne viral diseases globally, particularly affecting tropical and subtropical regions including Latin America, Southeast Asia, and parts of Africa. Brazil has experienced repeated dengue outbreaks in recent years, creating urgent demand for expanded vaccine supply and stronger disease prevention programs.
The partnership gained additional momentum in November 2025 after the single-dose Butantan-DV vaccine received ANVISA approval for use in individuals aged 12 to 59 years. Public health experts believe the vaccine could significantly strengthen Brazil’s national dengue prevention strategy and reduce the burden on healthcare systems during seasonal outbreak periods.
WuXi Vaccines Expands Global CDMO Leadership
The certification also highlights WuXi Vaccines’ growing influence within the global vaccine development and manufacturing sector. The company provides integrated CDMO solutions across multiple vaccine modalities including recombinant proteins, viral vectors, nucleic acid vaccines, virus-like particles (VLPs), outer membrane vesicles (OMVs), and conjugated vaccines.
Industry analysts note that global demand for vaccine manufacturing partnerships has increased significantly in recent years as pharmaceutical and biotechnology companies seek scalable production infrastructure, regulatory expertise, and flexible global supply chain solutions. WuXi Vaccines’ expanding GMP-certified manufacturing network positions the company as a critical strategic partner for vaccine developers aiming to accelerate commercialization and international distribution.
With increasing concerns over infectious disease outbreaks and pandemic preparedness worldwide, the latest ANVISA certification strengthens WuXi Vaccines’ ability to support global public health initiatives while reinforcing confidence in its manufacturing quality systems and regulatory compliance capabilities.
Source: WuXi Vaccines press release
