- AGC Biologics' Seattle site has over 30 years of experience in biopharmaceutical development and manufacturing.
- In 2025, the Seattle site achieved a 100% batch success rate, meeting all quality standards.
- The site has regulatory approval in more than 11 countries.
GMP Certification
AGC Biologics' Seattle facility has received Good Manufacturing Practice (GMP) certification from Brazil's National Health Surveillance Agency (Anvisa). This certification allows the Seattle site to supply biopharmaceutical products to Brazil, the largest pharmaceutical market in South America. It is the second AGC Group site to achieve this certification, following the Copenhagen site.
Experience and Quality
The Seattle site boasts over 30 years of experience in developing and manufacturing biopharmaceuticals using mammalian and microbial systems. In 2025, the site successfully passed all external audits, including customer audits, and achieved a 100% batch success rate, with all manufactured batches meeting quality standards.
Global Reach
With the latest certification, the Seattle site now has regulatory approval in more than 11 countries. This expansion strengthens AGC's cross-regional supply capabilities, supported by a globally integrated quality system and technical collaboration among its sites.
