AGC Biologics’ Seattle Site Achieves Successful Multi-Product Inspection by U.S. Food and Drug Administration for Biologics License Applications
AGC Biologics, a Seattle-based biomanufacturer, announced that its Seattle campus achieved a new milestone for regulatory compliance in partnership with the Food and Drug Administration (FDA).
The site conducted a comprehensive inspection to support Biologics License Applications (BLA) for new products seeking approval in the U.S., including a fusion protein-based drug for treating bladder cancer and a monoclonal antibody (mAb) for treating macular degeneration.
Michael Tranmer, General Manager of AGC Biologics Seattle, remarked, “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.”
This latest achievement reflects AGC Biologics’ ongoing role in cultivating innovation in the region, as evidenced by its three commercial approvals over the past two years.