AGC Biologics Seattle Facility Achieves Regulatory and Operational Milestones

AGC Biologics’ Seattle manufacturing facility has reached significant milestones in 2025, reinforcing its role as a key player in the biopharmaceutical industry. The site successfully completed a routine U.S. Food and Drug Administration (FDA) surveillance inspection in April 2025, following a 2024 Pre-License Inspection that led to FDA approval for commercial production of three Biologics License Applications.

The facility also secured regulatory product approvals in ten countries, including the U.S., European Union, Canada, U.K., China, and Australia. Additionally, it achieved ISO 45001 and 14001 certifications with zero findings in emergency management and occupational health and safety systems. The Seattle site completed six customer audits in 2025 and maintained a 100% batch success rate, underscoring its commitment to quality and reliability.

“With increased safety and quality compliance combined with a perfect batch success rate, we bring added value to our current customers and are well prepared to welcome new projects,” said Christoph Winterhalter, Chief Business Officer, AGC Biologics. “The Seattle site team is accelerating our operational excellence and inspires us globally to continue that momentum into 2026 with current and future partnerships.”

In tandem with these achievements, Marty Shawala was promoted to Senior Vice President of Quality on September 1, 2025. Shawala, with 26 years of experience from prior roles at Merck, Sanofi, and Takeda, will oversee quality functions across AGC Biologics’ global network of cGMP manufacturing sites.

The Seattle facility’s performance bolsters the Pacific Northwest’s standing as a life sciences hub. The site supports both mammalian and microbial-based protein production and recently onboarded its first microbial customer, expanding its capabilities. These accomplishments position AGC Biologics Seattle as a reliable partner for U.S.-based biologic manufacturing.