AGC Biologics’ Seattle site passes FDA inspection, hits quality milestones

AGC Biologics, a global contract development and manufacturing organization, said its Seattle manufacturing facility achieved multiple regulatory and quality milestones in 2025. 

The accomplishments included a successful U.S. Food and Drug Administration surveillance inspection in April, following a 2024 pre-license inspection that supported three biologics license applications later approved for commercial production.

The facility also reported regulatory approvals spanning 10 countries, including the U.S., European Union, Canada, United Kingdom, China, and Australia. In addition, ISO 45001 and 14001 audits covering occupational health, safety and emergency management yielded zero findings, according to the company. Seattle operations also completed six customer audits and achieved a 100% batch success rate this year.

In recognition of these efforts, the company appointed Marty Shawala as senior vice president of quality on Sept. 1. Shawala, who previously held quality leadership roles at Merck, Sanofi, and Takeda, will oversee quality functions across AGC Biologics’ global network.

“Quality excellence is a minute-by-minute, day-to-day achievement that requires ongoing vigilance, but it’s fulfilling to look back and see the positive trajectory we are creating in Seattle through embracement of operational excellence and continuous improvement,” Shawala said in a statement.

The Seattle site produces both mammalian and microbial-based proteins and recently onboarded its first microbial customer as part of its expanding capabilities, according to the announcement.