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
Seattle
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October 17, 2024 05:57 AM Eastern Daylight Time
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced the U.S. Food and Drug Administration (FDA)’s approval of a third Biologics License Applications (BLA) from the March 2024 inspection of the company’s 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.
The Seattle CDMO facility 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. AGC Biologics 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.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.
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AGC Biologics
Nick McDonald
+1 425-419-3555
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