AGC Biologics Seattle Facility Achieves Regulatory and Operational Milestones
AGC Biologics’ Seattle facility has achieved major regulatory and operational milestones in 2025.
The site passed an FDA surveillance inspection, secured approvals in ten countries, and earned ISO 45001 and ISO 14001 certifications, while maintaining a 100% batch success rate. Chief Business Officer Christoph Winterhalter remarked, “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.”
These accomplishments reinforce Seattle’s capabilities in both mammalian and microbial biologic production.