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, MD. “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 centres 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.

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases and focussed on rare diseases and multiple sclerosis.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.