Genzyme, a Sanofi company, is investing $80 million to build a new downstream processing facility for Fabrazyme® (agalsidase beta). The new plant, which will be located adjacent to the new Fabrazyme cell culture manufacturing site in Framingham, Massachusetts, will significantly expand purification capacity to support anticipated growth in global demand over the coming years.
“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 Genzyme President and CEO, David Meeker, M.D. “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.