On February 3, 2026, AGC Biologics’ manufacturing site in Seattle successfully obtained Good Manufacturing Practices (GMP) certification from Agência Nacional de Vigilância Sanitária (Anvisa), the Brazilian health regulatory authority.
Strategic impact of Anvisa authorization
This certification enables biologics and biosimilars produced at the Seattle site to be commercialized in Brazil, the largest pharmaceutical market in South America, valued at approximately $40 billion.
Gaining approval from a rigorous agency like Anvisa confirms that the facility’s quality systems meet global expectations beyond standard FDA or EMA requirements. This achievement significantly de-risks the path to international commercialization for AGC Biologics’ global partners.
Global regulatory track record
The Seattle facility is now the second site in the AGC Biologics network to be Anvisa-certified, following the Copenhagen site’s approval in 2023. This shared status facilitates seamless technology transfers across the company’s network. Key performance indicators for the Seattle site include:
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International Recognition: Now recognized as cGMP-certified across 11 different countries, demonstrating compliance with diverse global standards.
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Operational Excellence: In 2025, the site successfully completed 11 customer audits and maintained a 100% batch success rate.
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Safety & Environment: Achieved zero-finding ISO 45001 and ISO 14001 certification audits.
Facility capabilities
The 150,000-square-foot Seattle campus supports flexible fed-batch and perfusion manufacturing processes. It serves as AGC Biologics’ global Center of Excellence for formulation services and provides robust scale-up capabilities from clinical stages to commercial supply under current ICH and cGMP standards.