AGC Biologics Seattle site gains GMP certification from Brazil’s Anvisa

AGC Biologics, a contract development and manufacturing organization (CDMO), said its Seattle manufacturing site received Good Manufacturing Practices (GMP) certification from Brazil’s Agência Nacional de Vigilância Sanitária, enabling biologics and biosimilars produced at the facility to be commercialized in Brazil.

The certification allows customers using the Seattle site to access Brazil’s pharmaceutical market, the largest in South America, according to the company.

“This certification ensures that our customers are able to deliver product to patients in need of treatment in the Brazilian market,” Marty Shawala, senior vice president of quality at AGC Biologics, said in a statement. “It reflects how our teams work collaboratively across departments and throughout the network to meet required quality standards and maintaining the business strategy associated with our customer’s regulatory submission.”

According to the announcement, the Seattle site has now achieved current GMP certification in 11 countries. AGC Biologics said the facility is the second site in its network to receive Anvisa GMP certification, following its Copenhagen facility, which was certified by the Brazilian regulator in 2023. The shared approval status can support technology transfers between sites.

In September 2025, the U.S. Food and Drug Administration issued a final Establishment Inspection Report confirming full cGMP compliance at the Seattle site. During 2025, the facility completed 11 customer audits, achieved ISO 45001 and ISO 14001 certifications with zero nonconformities, and reported a 100% batch success rate, according to AGC Biologics.

“With every inspection, our team becomes more prepared for the next, and this Anvisa certification is a testament to that momentum as well as the strength of our global quality systems,” Kathleen Retzloff, senior director of quality at the Seattle site, said in a statement.

The 150,000-square-foot Seattle campus supports fed-batch and perfusion processes and serves as the company’s center of excellence for global formulation services.