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

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SEATTLE--(BUSINESS WIRE)--Sep 10, 2025--

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 systems.
• The facility successfully completed six customer audits in 2025 and achieved a batch success rate of 100 percent, demonstrating consistent quality standards that attract new partnerships.

“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.”

As a result of the exceptional efforts underway in Seattle, Marty Shawala was appointed to an executive leadership position at AGC Biologics on September 1. In his new role as Senior Vice President of Quality, Marty will provide strategic leadership for all quality-related functions across AGC Biologics’ global network of cGMP manufacturing sites and development operations. Marty brings 26 years of experience and understanding of regulatory frameworks, including knowledge from his previous quality roles at Merck, Sanofi, and Takeda.

“Quality excellence is a minute-by-minute, day-to-day achievement that requires ongoing vigilance, but it’s fulfilling to look back and see the positive trajectory we are creating in Seattle through embracement of operational excellence and continuous improvement,” said Marty Shawala. “This requires the dedication of every team member, and we celebrate our achievements by continuing to strengthen on our safety and quality efforts and spreading this culture throughout our global network.”

The Seattle facility's performance strengthens the Pacific Northwest's position as a leading life sciences hub, with the region ranked ninth in Genetic Engineering & Biotechnology News' 2025 global life sciences clusters list. The facility serves as a critical manufacturing node for both mammalian and microbial-based protein production, recently welcoming its first microbial customer as part of expanding capabilities.

This track record of regulatory compliance and manufacturing excellence positions AGC Biologics Seattle as an ideal partner for companies seeking reliable U.S.-based biologic manufacturing.

For more information on AGC Biologics’ Seattle site, visit https://www.agcbio.com/facilities/seattle.

About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.

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AGC Inc. corporate contact:[email protected] Biologics media contact:[email protected]

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SOURCE: AGC Biologics

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PUB: 09/10/2025 11:00 AM/DISC: 09/10/2025 11:01 AM

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