AGC Biologics Seattle Achieves Approval for all 2024 Biologics License Applications from U.S. Food and Drug Administration, Concluding Pre-License Inspection

Q1 2024 inspection results in three new commercial approvals for manufacturing

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).

The series of 2024 BLA approvals continues a trend of successful regulatory milestones for the AGC Biologics Seattle site. The FDA has approved four biologics products manufactured at this facility in the last two years. We received commercial approval at the end of 2022 for a mAb product targeting type 1 diabetes (T1D), the first and only treatment of its type at the time of approval.

"Performing an agency inspection for three products simultaneously is not easy and I am extremely proud of this result. We took on the challenge and helped ensure every product evaluated achieved commercial approval this year," said Jose Gonzalez, General Manager, AGC Biologics Seattle. "This is a tremendous achievement for our site. For our partners bringing lifesaving treatments to patients, it is pivotal for their manufacturing partner to maintain regulatory compliance and a high level of product quality to help them reach commercial success. This is a shining example of AGC Biologics' Seattle ability to do that."

AGC Biologics operates multiple mammalian cGMP manufacturing lines of various scales at its Seattle site, which serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes. In the past year, AGC Biologics Seattle has also expanded to include a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse to further enhance the quality, efficiency and operational excellence of the site.

To learn more about AGC Biologics' protein biologics manufacturing site in Seattle, visit www.agcbio.com/facilities/seattle. For more information on the company's end-to-end global CDMO services in the U.S., Europe and Japan visit www.agcbio.com.