- AGC Biologics’ Seattle facility completed multiple regulatory inspections and achieved a 100% batch success rate in 2025.
- The company appointed Marty Shawala as Senior Vice President of Quality to oversee global quality operations.
AGC Biologics has announced a series of milestones at its Seattle manufacturing facility in 2025, underscoring its focus on regulatory compliance and operational performance.
In April, the site successfully completed a routine surveillance inspection by the U.S. Food and Drug Administration (FDA), following a 2024 Pre-License Inspection that supported three Biologics License Application approvals. All three products were approved for commercial production by the FDA. The facility also secured product approvals across ten countries, including the U.S., EU, Canada, UK, China and Australia.
Seattle further advanced its compliance profile by passing ISO 45001 and 14001 certification audits with zero findings. Six customer audits were completed during the year, and the facility reported a 100% batch success rate. “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 at AGC Biologics.
As part of strengthening its global quality operations, the company appointed Marty Shawala as Senior Vice President of Quality on 1 September. Shawala, who has held leadership roles at Merck, Sanofi and Takeda, will oversee quality functions across AGC Biologics’ worldwide cGMP manufacturing network.
The Seattle facility plays a central role in the company’s mammalian and microbial-based protein production, having recently welcomed its first microbial customer. Its performance supports the Pacific Northwest’s growing life sciences sector, which was ranked ninth globally by Genetic Engineering & Biotechnology News in 2025.
