Two WuXi Biologics Manufacturing Facilities, Packaging Center Get Brazil GMP Certification

Editor’s Note: New GMP certifications add to WuXi’s list of global regulatory clearances.

WuXi Biologics received good manufacturing practice (GMP) certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for three facilities. All—Drug Substance Facility 2 (MFG2), Drug Product Facility 1 (DP1), Drug Product Packaging Center (DPPC)—are in Wuxi, China.

How Designations Advance WuXi Capabilities

For WuXi Biologics, the designations clear a path to offer end-to-end commercial manufacturing services for an anti-PD-L1 monoclonal antibody. The antibody is used in cancer immunotherapy; WuXi’s services cover both drug substance and drug product.

ANVISA found zero flags in its five-day inspection of MFG2, DP1, and DPPC, according to WuXi. The company’s quality management system, GMP execution, and capacity for cross-functional collaboration were put to the test.

Additionally, WuXi Biologics said the ANVISA inspection verified its capabilities to support client needs for global commercial manufacturing and supply.

MFG2, DP1, and DPPC offer large-scale biologics drug substance manufacturing, both clinical and commercial drug product fill-finish, and customized packaging.

Brazil a Sign of Things to Come?

ANVISA’s certifications add to WuXi’s satisfaction of regulatory requirements across major worldwide markets. As of 2025, the company reported 46 successful regulatory inspections—22 by either the U.S. FDA or European Medicines Agency.

“Receiving ANVISA GMP certification reflects WuXi Biologics’ continued commitment to global quality and compliance standards,” CEO Chris Chen, PhD, said. “[It] further validates our international standards across facilities, quality systems, and GMP execution. We will continue to leverage our world-class quality system and end-to-end manufacturing capabilities to enable clients’ global commercialization strategies.”

Chen said a specific focus for WuXi going forward is entry into Latin America.

Beyond the latest from ANVISA, WuXi Biologics has passed more than 1800 GMP quality audits globally. The company operates 15 GMP-certified drug substance and drug product facilities in its global network.