- AGC Biologics has received Good Manufacturing Practices certification from Brazil’s regulator Anvisa for its Seattle manufacturing facility.
- The approval enables biologics and biosimilars produced at the site to be commercialized in Brazil and supports AGC Biologics’ CDMO and contract manufacturing services.
AGC Biologics has announced that its Seattle manufacturing facility has received Good Manufacturing Practices certification from Brazil’s health regulator, Agência Nacional de Vigilância Sanitária (Anvisa). The approval allows biologics and biosimilars manufactured at the site to be commercialized in Brazil, expanding market access for customers in South America.
The certification confirms the Seattle site’s compliance with Anvisa’s regulatory requirements and supports the company’s role as a CDMO providing contract manufacturing services for biologics and biosimilars. According to the company, the approval enables customers to include the Seattle facility in regulatory submissions for the Brazilian market.
“This certification ensures that our customers are able to deliver products to patients in need of treatment in the Brazilian market. The result reflects cross-functional collaboration and alignment with customer regulatory strategies.”
Marty Shawala, Senior Vice President, Quality, AGC Biologics
The Anvisa approval builds on the Seattle site’s recent regulatory track record. In September 2025, the facility received confirmation of full cGMP compliance from the U.S. Food and Drug Administration, and it is now certified to supply product to 11 countries. Seattle is the second AGC Biologics site to receive Anvisa GMP certification, following approval of the Copenhagen facility in 2023.
AGC Biologics said the 150,000-square-foot Seattle campus supports fed-batch and perfusion manufacturing and serves as the company’s Center of Excellence for global formulation services. The site uses single-use technologies and follows current ICH guidelines to support scale-up from clinical to commercial supply while maintaining cGMP compliance.
