AGC Biologics’ Seattle manufacturing facility has received Good Manufacturing Practices (GMP) certification from Brazil’s health regulatory authority, Agência Nacional de Vigilância Sanitária (Anvisa). The certification allows biologics and biosimilars manufactured at the site to be commercialized in Brazil, the largest pharmaceutical market in South America.

“This certification ensures that our customers are able to deliver product to patients in need of treatment in the Brazilian market,” said Marty Shawala, Senior Vice President, Quality, AGC Biologics. “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.”

The Anvisa certification adds to the Seattle site’s regulatory track record. In September 2025, the U.S. Food and Drug Administration issued a final Establishment Inspection Report confirming full compliance with current GMP requirements. The site is now recognized as cGMP certified across 11 countries.

Seattle is the second AGC Biologics manufacturing site to receive GMP certification from Anvisa, following approval of the company’s Copenhagen facility in 2023. The shared certification status can support technology transfers between sites. In 2025, the Seattle site completed 11 customer audits, achieved ISO 45001 and ISO 14001 certifications with no non-conformities, and reported a 100% batch success rate.

“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,” said Kathleen Retzloff, Senior Director of Quality for AGC Biologics’ Seattle site. “We are laser-focused on helping our customers achieve even more regulatory success in the year ahead.”

The 150,000‑square‑foot Seattle campus supports fed-batch and perfusion manufacturing, serves as AGC Biologics’ center of excellence for formulation services, and supports clinical-to-commercial scale-up under current ICH and cGMP standards.