AGC Biologics, a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced a significant milestone for its Seattle campus. In March 2024, the site completed a multi-product inspection by the U.S. Food and Drug Administration (FDA) to support Biologics License Applications (BLA) for new products aiming for commercial approval in the United States. The inspection resulted in the approval of two products for commercial production: a fusion protein-based drug for treating bladder cancer and a monoclonal antibody (mAb) for treating macular degeneration.
These approvals are particularly noteworthy as they underscore the Seattle site's ability to manage complex regulatory processes and maintain high standards of quality and compliance. Michael Tranmer, General Manager of AGC Biologics Seattle, highlighted the importance of this achievement, stating, "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."
The Seattle facility is not new to such achievements. It has produced six commercial products for AGC Biologics, including three commercial approvals in the last two years. The site is also actively engaged in helping clients navigate clinical milestones, working with several clinical-stage companies, and anticipating more commercial license application submissions in the next 18 to 24 months.
AGC Biologics Seattle operates multiple mammalian cGMP manufacturing lines and employs a variety of scales. The campus serves as a center of excellence for formulation, utilizing the latest fed-batch and perfusion manufacturing processes. Over the past year, the site has expanded its capabilities by adding a new microbial-based manufacturing line system and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse. These enhancements are aimed at improving the quality, efficiency, and operational excellence of the facility.
The approval of these two biologics not only validates the expertise and operational capabilities of AGC Biologics Seattle but also has significant implications for the broader pharmaceutical industry. The fusion protein-based drug for bladder cancer and the monoclonal antibody for macular degeneration are expected to meet critical medical needs, offering new treatment options for patients. The facility's ability to deliver multiple batches per year and accommodate future demand increases further bolsters its reputation as a reliable partner for biopharma companies seeking to bring products from clinical stages to commercial approval.
For more information on 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.
