Seattle, WA, Oct. 16, 2024 — Today, we announced the U.S. Food and Drug Administration (FDA)’s approval of a third Biologics License Applications (BLA) from the March 2024 inspection at our Seattle facility. The closure of this inspection and final BLA approval resulted in each of the three commercial products evaluated being approved for commercial production – a regulatory compliance and quality milestone for the site.

AGC Biologics Seattle site welcomed the FDA in March 2024 for an intensive week of three product inspections. The approved products include two FC-fusion proteins and a monoclonal antibody (mAb). One of the FC-fusion proteins is focused on treating non-muscle invasive bladder cancer; the other is designed to treat age-related neovascular Macular Degeneration (nAMD) and other serious retinal diseases. The mAb product targets chronic-versus-host disease (GVHD). 

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