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AGC Biologics Seattle Facility Achieves Milestone Year with Regulatory Approvals, Customer Satisfaction and Zero-Finding ISO Certification Inspection

AGC INC UNSP/ADR (ASGLY) 
Company Research Source: Business Wire
Manufacturing excellence positions Seattle site as premier destination for mammalian and microbial biologic production in thriving Pacific Northwest life sciences hub SEATTLE--(BUSINESS WIRE)--AGC Biologics today announced that its Seattle manufacturing facility achieved significant milestones in 2025, showcasing the facility's commitment to operational excellence. Those milestones included successful execution of a U.S. Food & Drug Administration routine site surveillance inspection in April 2025 which followed the 2024 Pre-License Inspection performed for three Biologics License Application approvals, of which all three products were approved for commercial production by the FDA.Other regulatory and quality milestones in Seattle include:Regulatory product approvals spanning ten different countries, including U.S., EU, Canada, UK, China, and Australia.ISO 45001 and 14001 certification audit that yielded zero findings across emergency management and occupational health and safety s Show less Read more
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