- AGC Biologics’ Seattle site received FDA approval for three Biologics License Applications (BLAs) following a March 2024 inspection.
- The approved products include two FC-fusion proteins and a monoclonal antibody targeting diseases such as bladder cancer, retinal diseases, and chronic GVHD.
AGC Biologics announced that the U.S. Food and Drug Administration (FDA) approved three Biologics License Applications (BLAs) from a March 2024 inspection at its Seattle facility. The inspection, which covered three commercial biologics, resulted in the approval of two FC-fusion proteins and a monoclonal antibody (mAb) for commercial production.
The FDA inspection took place over an intensive week in March, evaluating the production of treatments for non-muscle invasive bladder cancer, age-related neovascular macular degeneration (nAMD), and chronic-versus-host disease (GVHD). This marks the third successful BLA approval for the Seattle facility this year.
This series of BLA approvals continues a pattern of regulatory success for the site, which has seen four biologics approvals in the past two years. One notable approval was a monoclonal antibody targeting type 1 diabetes in late 2022, which was the first of its kind at the time.
“Performing an agency inspection for three products simultaneously is not easy, and I am extremely proud of this result,” said Jose Gonzalez, General Manager of AGC Biologics Seattle. “It is pivotal for our partners to have a manufacturing partner that maintains regulatory compliance and high product quality. This is a shining example of AGC Biologics Seattle’s ability to do that.”
AGC Biologics operates several mammalian cGMP manufacturing lines at its Seattle site and has recently expanded its capabilities with a new microbial-based manufacturing line and a 67,000 sq. ft. GMP-compliant warehouse.
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