AGC Biologics’ Seattle Site Achieves Successful Multi-Product Inspection by U.S. Food and Drug Administration for Biologics License Applications CDMO site shares promising outcomes after in Q1 2024 FDA inspections and is now producing two new products for commercial usage in the U.S.
Seattle, WA
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July 29, 2024 05:30 AM Pacific Daylight Time
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today that its Seattle Campus completed a new commercial milestone for regulatory compliance in 2024. The site supported a multi-product inspection in March 2024 with the Food and Drug Administration (FDA) to support Biologics License Applications (BLA) for new products seeking commercial approval in the U.S., 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.
“This achievement is significant for this site, our team members and our partners in the pharmaceutical industry seeking to bring products from clinical stages to commercial approval,” notes Michael Tranmer, General Manager of AGC Biologics Seattle. “Inspections for multiple products at one time is not easy. This accomplishment is a true testament to our commitment to quality and regulatory compliance and helping developers reach their goals as fast and efficiently as possible.”
This is the latest achievement for the Seattle-based CDMO manufacturing site, which has produced six commercial products for AGC Biologics. This includes three commercial approvals in the last two years. AGC Biologics Seattle is active in helping clients navigate clinical milestones, as well. The site team is working with several clinical-stage companies and predicts more commercial license application submissions in the coming 18 to 24 months.
AGC Biologics runs multiple mammalian cGMP manufacturing lines and a variety of scales at its Seattle site. The campus serves as a center of excellence for formulation and employs the latest fed-batch and perfusion manufacturing processes. Over the last year, AGC Biologics Seattle has also expanded. This work includes 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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Nick McDonald
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