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.

Today, we announced that our 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 our Seattle manufacturing site, which has produced six commercial products for AGC Biologics. This includes three commercial approvals in the last two years. The 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 our 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.