The site supported a multi-product inspection in March 2024 with the Food and Drug Administration to support Biologics License Applications for new products seeking commercial approval in the US, two of which are now approved for commercial production at the facility.
The two approved products include a fusion protein-based drug for treating bladder cancer and a monoclonal antibody (mAb) for treating macular degeneration. AGC Biologics Seattle predicts delivering multiple batches per year for the biopharma partners that received the approvals and accommodating increases in future demand.