AGC Biologics' Seattle Facility Passes FDA Inspection for Multiple Biologics License Applications

AGC Biologics, a global leader in biopharmaceutical contract development and manufacturing, has achieved a significant regulatory milestone at its Seattle facility. The company announced that its Seattle campus successfully completed a multi-product inspection by the U.S. Food and Drug Administration (FDA) in March 2024, supporting Biologics License Applications (BLAs) for new products seeking commercial approval in the United States.

The inspection resulted in the approval of two new products for commercial production at the facility. These include a fusion protein-based drug for treating bladder cancer and a monoclonal antibody (mAb) for treating macular degeneration. AGC Biologics anticipates delivering multiple batches per year for the biopharma partners that received these approvals, with the capacity to accommodate future increases in demand.

Michael Tranmer, General Manager of AGC Biologics Seattle, emphasized the significance of this achievement, stating, "This accomplishment is a true testament to our commitment to quality and regulatory compliance and helping developers reach their goals as fast and efficiently as possible." The successful multi-product inspection demonstrates AGC Biologics' ability to navigate complex regulatory processes and support its partners in bringing new therapies to market.

This latest accomplishment adds to the Seattle site's impressive track record, which now includes the production of six commercial products for AGC Biologics, with three commercial approvals in the last two years alone. The facility is also actively supporting several clinical-stage companies and anticipates more commercial license application submissions in the next 18 to 24 months.

AGC Biologics' Seattle campus is equipped with multiple mammalian cGMP manufacturing lines at various scales and serves as a center of excellence for formulation. The site employs advanced fed-batch and perfusion manufacturing processes, ensuring high-quality production of biopharmaceuticals. Recent expansions at the facility include a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse, further enhancing the site's capabilities and operational excellence.

The successful FDA inspection and subsequent approvals highlight AGC Biologics' role in advancing the biopharmaceutical industry. By providing robust manufacturing capabilities and navigating complex regulatory landscapes, the company is enabling the development and commercialization of innovative therapies that have the potential to improve patient outcomes in areas such as cancer treatment and ophthalmology.

As part of AGC Inc.'s Life Science Company, AGC Biologics operates within a broader network of global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. With over 2,500 employees worldwide, the company's commitment to continuous innovation and specialization in fast-track projects and rare diseases positions it as a key player in the biopharmaceutical CDMO space.

For more information on AGC Biologics' protein biologics manufacturing capabilities in Seattle, interested parties can visit www.agcbio.com/facilities/seattle. Additional details about the company's comprehensive global CDMO services across the United States, Europe, and Japan are available at www.agcbio.com.