AGC Biologics Wins 2026 Fierce Outsourcing Award For Leadership In Regulatory And Quality Compliance
AGC Biologics received the 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance in recognition of its regulatory strategy, quality systems, and compliance performance.
The Seattle-based CDMO was recognized after completing nine successful regulatory inspections in 2025 from seven global health authorities and supporting five new product approvals for partners. AGC Biologics reported more than 100 successful regulatory inspections, over 30 commercial product approvals, and experience supporting more than 400 products for more than 250 customers. “We are humbled and grateful for the rigor of regulatory agencies around the world that help us in our journey of continuous quality improvement,” said Alberto Santagostino, CEO and President of AGC Biologics.
The company’s continued global expansion, including a new Yokohama manufacturing facility with advanced mammalian, cell therapy, and mRNA capabilities, reinforces the Pacific Northwest’s role in advancing high-quality biomanufacturing and global life sciences innovation.