AGC Biologics' Seattle Site Completes Successful FDA Inspection for Biologics License Applications
TL;DR
AGC Biologics Seattle achieves new commercial milestone for regulatory compliance, supporting multiple product inspections and approvals, gaining competitive advantage.
AGC Biologics Seattle campus completed a new commercial milestone for regulatory compliance, supporting multiple product inspections and approvals, utilizing cGMP manufacturing lines and state-of-the-art processes.
AGC Biologics Seattle's new commercial milestone for regulatory compliance helps bring life-saving treatments for bladder cancer and macular degeneration to market, improving patient care and quality of life.
AGC Biologics Seattle campus achieves significant commercial milestone for regulatory compliance with FDA, supporting new treatments for bladder cancer and macular degeneration.
Found this article helpful?
Share it with your network and spread the knowledge!
AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced a significant milestone at its Seattle Campus. The facility successfully completed a multi-product inspection by the U.S. Food and Drug Administration (FDA) in March 2024, supporting Biologics License Applications (BLA) for new products aiming for commercial approval in the U.S.
The inspection resulted in the approval for commercial production of two new products: a fusion protein-based drug for treating bladder cancer and a monoclonal antibody (mAb) for treating macular degeneration. AGC Biologics Seattle plans to deliver multiple batches annually for its biopharma partners and expects to meet increasing future demand.
Michael Tranmer, General Manager of AGC Biologics Seattle, emphasized the importance of this achievement. “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,” he stated.
This accomplishment is the latest for the Seattle-based CDMO site, which has produced six commercial products, including three commercial approvals in the last two years. The site is also actively involved in helping clients navigate clinical milestones, predicting more commercial license application submissions in the next 18 to 24 months.
The Seattle facility operates multiple mammalian cGMP manufacturing lines and utilizes advanced fed-batch and perfusion manufacturing processes. Over the past year, the site has expanded to include a new microbial-based manufacturing line and a state-of-the-art 67,000 sq. ft. GMP-compliant warehouse, enhancing its quality, efficiency, and operational excellence.
For more information on AGC Biologics' Seattle facility, visit www.agcbio.com/facilities/seattle. For more information on the company’s end-to-end global CDMO services, visit www.agcbio.com.
Curated from News Direct
