17 Oct 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Genzyme, a Sanofi company, plans to invest USD80 million to build a new downstream processing facility for Fabrazyme (agalsidase beta) to expand purification capacity to support anticipated growth in global demand over the coming years.
The new plant will be located close to the new Fabrazyme cell culture manufacturing site in Framingham, Massachusetts.
"As we continue to meet the global demands for Fabrazyme and build inventory, our focus also remains on the future needs of the global Fabry community," said Mr. David Meeker, President and CEO, Genzyme. "Following last year's regulatory approvals of our manufacturing facility in Framingham and a new vial filling line at our plant in Waterford, Ireland, we continue to execute on our global manufacturing strategy, enhancing our capabilities across the entire manufacturing process for Fabrazyme."
Downstream processing, a vital step in biologic production, involves the purification of material harvested from the cell culture manufacturing process. The final product, which is administered as an intravenous (IV) infusion, is formulated and fill-finished in a separate facility in Waterford, Ireland and shipped to multiple distribution centers for labeling, packaging and shipping around the world.
Fabrazyme is approved for treatment of Fabry disease, an inherited condition that is characterized by excessive accumulation of the lipid GL-3 in various organs and tissues, which over time can cause renal, cardiac and cerebrovascular events. As a result, patients with Fabry disease typically have a shortened life span, and children must often cope with significant pain and disability. Fabry disease is an inherited and life threatening disease linked to the X chromosome which affects approximately 5,000 patients in the world.