WuXi Biologics, a contract research, development and manufacturing organization (CRDMO) headquartered in Shanghai, China, has received GMP certification from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) for three of its Wuxi, China facilities — Drug Substance Facility 2, Drug Product Facility 1, and its Drug Product Packaging Center — enabling end-to-end commercial manufacturing of an anti-PD-L1 monoclonal antibody used in cancer immunotherapy.

The certification was granted following a five-day inspection with zero findings, according to the announcement. The three facilities collectively provide large-scale biologics drug substance manufacturing, clinical and commercial drug product fill-finish, and customized packaging capabilities, the company said.

Chris Chen, CEO of WuXi Biologics, said in a statement the ANVISA certification validates the company’s international quality systems and GMP execution, and that the company will continue to leverage its manufacturing capabilities to support clients’ global commercialization strategies including entry into Latin America.

WuXi Biologics said it has passed 46 regulatory inspections to date, including 22 conducted by the FDA and EMA, with a 100% pass rate, and holds 136 facility license approvals. The company has also passed more than 1,800 GMP quality audits by global clients, including more than 230 audits by EU Qualified Persons, according to the company.

The certification follows other recent regulatory and manufacturing milestones at WuXi Biologics. In late June, the company completed its first GMP production campaign at MFG17, its 25th drug substance facility, at the Shanghai Fengxian site, with the manufacturing process completed with zero deviations and yields reaching expected levels.