Shire has submitted regulatory filings with both the European Medicines Agency and the FDA for the production of VPRIV (velaglucerase alfa) in its manufacturing facility in Lexington, Mass.
Subject to regulatory approval, which is anticipated in early 2012, Shire expects the plant to increase manufacturing capacity and allow for increased global supply of VPRIV. These approvals will also make available further capacity for the manufacture of Replagal (agalsidase alfa) at Shire’s Alewife facility, where both VPRIV and Replagal are manufactured.
“Once approved, this new facility will give us greater flexibility to meet the global demand for VPRIV as well as some of our other products for rare diseases,” says Bill Ciambrone, senior vice president, Technical Operations, Shire HGT.
Release Date: Nov. 22, 2011