Shire has received approval from the European Medicines Agency’s (EMA) for the production of VPRIV (velaglucerase alfa) at its new manufacturing facility in Lexington, MA. The company also has an EMA approved facility in Cambridge, MA, for the manufacture of VPRIV drug substance. This additional capacity allows the company to significantly increase global supply of VPRIV and provides additional manufacturing flexibility. The new facility increases bioreactor capacity from 1000 to 8000L, and is among the first commercially licensed facilities to use single-use bioreactor and disposable technology throughout cell culture processing.

“I am delighted to announce the EMA approval of our facility. Shire has invested strategically in new manufacturing facilities and state-of-the-art technology because we recognize the critical importance of ensuring the continuity of treatment for patients with rare and life-threatening diseases,” said Bill Ciambrone, senior vice president of Technical Operations, Shire HGT. “The EMA approval of VPRIV in this manufacturing plant, only three years after breaking ground, is a testament to the hard work and dedication of Shire employees, and represents crucial additional capacity for manufacturing our enzyme replacement therapies for Gaucher and Fabry patients.”