AGC Biologics Seattle Facility Celebrates Milestone Year with Regulatory Approvals, Quality Achievements, and Leadership Expansion
AGC Biologics, a leading global contract development and manufacturing organization (CDMO), has announced that its Seattle, Washington facility has achieved a series of remarkable milestones in 2025. The accomplishments underscore not only the site’s commitment to operational excellence but also its growing importance in the company’s global network of biologics manufacturing facilities.
The Seattle site, already recognized as one of the company’s cornerstone facilities for biologics development and production, delivered a record-setting year that included major regulatory approvals, flawless quality inspections, and customer-driven performance indicators. Collectively, these achievements reinforce AGC Biologics’ position as a trusted partner in the biopharmaceutical industry and set the stage for continued growth in 2026 and beyond.
Regulatory Successes Cement Seattle’s Role in Global Biologics Production
One of the most significant highlights of 2025 was the Seattle facility’s success in regulatory compliance and inspection readiness.
In April 2025, the site underwent a routine surveillance inspection conducted by the U.S. Food and Drug Administration (FDA). The inspection followed a 2024 Pre-License Inspection (PLI) that was tied to three Biologics License Applications (BLAs). All three BLAs received FDA approval, enabling commercial production of the associated therapies. This sequence of inspections and approvals underscored the facility’s consistent ability to meet stringent regulatory requirements, which is a critical measure of a CDMO’s reliability.
Beyond the United States, the facility achieved product approvals across ten countries, including the European Union, Canada, the United Kingdom, China, and Australia. This international footprint reflects both the high demand for AGC Biologics’ capabilities and the global standards that the Seattle facility has been able to meet and exceed. Each regulatory approval not only validates the quality and safety of the therapies manufactured at the site but also broadens patient access to life-saving biologic medicines worldwide.
Flawless ISO Certification Audits Demonstrate World-Class Quality Systems
In addition to its regulatory wins, the Seattle facility underwent ISO 45001 and ISO 14001 certification audits, both of which resulted in zero findings.
ISO 45001 certification focuses on occupational health and safety management systems, ensuring that the site provides a safe and healthy workplace environment for employees. ISO 14001, meanwhile, pertains to environmental management systems, reflecting the company’s dedication to sustainability and responsible operations.
That both audits concluded with zero findings is a rare accomplishment in the manufacturing world. It highlights the rigor with which the Seattle team maintains systems for safety, compliance, and environmental stewardship. These results also reassure AGC Biologics’ global clients that the facility operates under the highest possible standards in quality and sustainability—areas that are increasingly important as pharmaceutical companies look to reduce supply chain risks while maintaining corporate social responsibility commitments.
Customer Audits and Perfect Batch Success Rate Showcase Reliability
While regulatory approvals and certifications are crucial, CDMOs must also demonstrate consistency in day-to-day operations. In 2025, the Seattle site excelled in this area as well.
The facility successfully completed six customer audits, each conducted by biopharma partners seeking assurance that their products are being manufactured to exacting standards. Customer audits are typically highly detailed, probing not only compliance with Good Manufacturing Practices (cGMP) but also operational efficiency, risk management, and data integrity. The Seattle team’s ability to pass all six audits reflects both its preparedness and its customer-first approach.
Perhaps even more impressive was the facility’s achievement of a 100 percent batch success rate throughout the year. In the complex world of biologics manufacturing, where even minor deviations can result in failed batches, such a record is nearly unparalleled. This consistency ensures that clients can rely on AGC Biologics for uninterrupted supply of critical medicines, further strengthening trust and opening the door to new partnerships.
Christoph Winterhalter, Chief Business Officer at AGC Biologics, emphasized the importance of these accomplishments:
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. The Seattle site team is accelerating our operational excellence and inspires us globally to continue that momentum into 2026 with current and future partnerships.”
Leadership Expansion: Marty Shawala Appointed Senior Vice President of Quality
In recognition of the progress made in Seattle and across the company’s network, AGC Biologics also strengthened its executive leadership in 2025. On September 1, Marty Shawala was appointed Senior Vice President of Quality. In this role, he will oversee all quality-related functions across AGC Biologics’ global cGMP manufacturing and development operations.
Shawala brings more than 26 years of experience in the biopharmaceutical sector, with prior leadership positions at industry giants including Merck, Sanofi, and Takeda. His deep expertise in regulatory frameworks and quality systems positions him well to drive AGC Biologics’ global quality strategy.
Reflecting on the Seattle site’s recent achievements and his new role, Shawala stated:
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. This requires the dedication of every team member, and we celebrate our achievements by continuing to strengthen our safety and quality efforts and spreading this culture throughout our global network.”
Shawala’s appointment not only validates the importance of Seattle within AGC Biologics’ global operations but also signals the company’s intent to further integrate quality excellence into its long-term growth strategy.
Seattle’s Role in the Pacific Northwest Life Sciences Ecosystem
The Seattle facility’s strong performance is not only a win for AGC Biologics but also for the broader life sciences ecosystem in the Pacific Northwest. In 2025, the region was ranked ninth in the Genetic Engineering & Biotechnology News (GEN) global life sciences clusters list, reflecting its growing influence as a hub for biopharmaceutical innovation and manufacturing.
AGC Biologics Seattle plays a critical role in this ecosystem. The facility supports both mammalian and microbial-based protein production, offering versatility that few CDMOs can match. In 2025, the site welcomed its first microbial customer, marking a milestone in its expansion of capabilities. This diversification positions Seattle as a go-to partner for companies developing a wide range of biologic therapies, from monoclonal antibodies to next-generation protein-based medicines.
The site’s prominence also contributes to regional economic growth by attracting investment, creating high-skilled jobs, and fostering collaborations with local academic and research institutions.
AGC Biologics: A Trusted Partner in Global Biologics Manufacturing
AGC Biologics has built a reputation as one of the premier CDMOs serving the global biopharmaceutical industry. With facilities spanning North America, Europe, and Asia, the company provides end-to-end solutions in biologics development and manufacturing, from cell line development to commercial production.
The Seattle site’s 2025 milestones reflect the company’s broader philosophy of operational excellence, customer-centricity, and global impact. By combining regulatory expertise, quality systems, and innovative manufacturing platforms, AGC Biologics has positioned itself as a trusted partner for pharmaceutical and biotechnology companies worldwide.
The flawless regulatory inspections, global approvals, ISO certifications, and perfect batch record achieved this year are not isolated events but rather outcomes of a deeply ingrained culture of excellence. They also position AGC Biologics to take on more complex projects and meet the growing demand for biologics manufacturing capacity worldwide.
Building on Momentum into 2026
As the company looks to 2026, the momentum generated by the Seattle site will play a pivotal role in shaping AGC Biologics’ future. Several trends are expected to influence the trajectory of the biologics CDMO industry:
- Rising Demand for Biologics: With increasing investment in cell and gene therapies, monoclonal antibodies, and other advanced biologics, CDMOs like AGC Biologics are essential partners for innovators lacking in-house capacity.
- Global Regulatory Complexity: Achieving approvals across multiple geographies, as Seattle did in 2025, will become increasingly important as drug developers pursue simultaneous global launches.
- Focus on Sustainability: Zero-finding ISO 14001 audits highlight the importance of environmental management. Future success will depend on continued commitment to sustainable operations.
- Operational Resilience: The 100 percent batch success rate in Seattle demonstrates resilience, which is critical as supply chain disruptions remain a concern for the pharmaceutical sector.
- Leadership in Quality: With Shawala at the helm of global quality functions, AGC Biologics is poised to deepen its reputation for uncompromising quality.
AGC Biologics’ Seattle facility has set a new standard in 2025, achieving milestones that extend beyond regulatory compliance to embody a holistic culture of excellence, sustainability, and reliability. From flawless FDA inspections to global approvals, from zero-finding ISO audits to customer-driven success metrics, the site has proven itself as a flagship in AGC Biologics’ global network.
The appointment of Marty Shawala further strengthens the company’s leadership in quality, while Seattle’s growing role in the regional and global life sciences ecosystem underscores its importance for the future of biologics manufacturing.
As AGC Biologics moves into 2026, the Seattle facility’s achievements not only inspire confidence among current and future partners but also signal the company’s readiness to meet the next wave of challenges and opportunities in the biopharmaceutical industry.
For more information about AGC Biologics’ Seattle facility, visit https://www.agcbio.com/facilities/seattle.
