WuXi Vaccines Celebrates GMP Certification from Brazil's ANVISA for Vaccine Production

WuXi Vaccines Achieves GMP Certification from Brazil's ANVISA

WuXi Vaccines, a subsidiary of WuXi Biologics focused on contract development and manufacturing of vaccines, has recently announced that its filling and finishing facility in Suzhou, designated as DP17, has received Good Manufacturing Practices (GMP) certification from Brazil's national health agency, Agência Nacional de Vigilância Sanitária (ANVISA). This landmark achievement is a significant step towards enhancing the availability of high-quality vaccines within Brazil and beyond.

The certification process was comprehensive, involving detailed on-site inspections of the DP17 facility, which is equipped to handle both liquid and lyophilized (lyo) vaccine products. The facility encompasses not just the production lines but also quality assurance (QA), quality control (QC), warehouses, and utility systems, ensuring adherence to the highest manufacturing standards.

Jian Dong, CEO of WuXi Vaccines, expressed his excitement about this regulatory milestone. He remarked, "This certification validates the excellence of our world-class quality system and highlights our collaboration with Instituto Butantan in making dengue vaccines more accessible. We are committed to providing top-tier services and technologies to global partners, paving the way for better public health outcomes."

The successful certification comes as WuXi Vaccines embarks on a substantial agreement with Instituto Butantan and Fundação Butantan. As part of this partnership, WuXi will deliver an end-to-end service model that spans drug substance manufacturing to quality control and production of the final vaccine product. The goal is to rapidly scale up the production capacity for Butantan-DV, a dengue vaccine, to protect Brazil's population effectively. It is anticipated that millions of doses will be delivered to meet the pressing health needs of the country.

This announcement comes on the heels of Butantan-DV receiving approval from ANVISA in November 2025, allowing its administration to individuals aged between 12 and 59. The rapid progression from development to regulatory approval and now manufacturing certification underscores the urgency and importance of dengue prevention in Brazil, where the disease poses significant health risks annually.

WuXi Vaccines stands at the forefront of vaccine development and manufacturing, offering integrated services that expedite the journey from initial research to market delivery. The company is equipped with advanced capabilities across various production platforms, ensuring it can handle diverse vaccine modalities, from recombinant proteins to viral vectors. This versatility not only streamlines the manufacturing process but also enhances the reliability and speed of vaccine production, all while adhering to stringent regulatory requirements.

As countries globally continue to grapple with vaccine access and public health challenges, WuXi Vaccines' certification from ANVISA represents a critical advancement in the effort to combat infectious diseases. The company's commitment to quality, innovation, and collaboration will play a pivotal role in shaping the future landscape of vaccine accessibility and affordability, protecting public health on a global scale.

For further details about WuXi Vaccines and their services, visit WuXi Vaccines.