Shire announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has approved the production of VPRIV (velaglucerase alfa) in its new state-of-the-art manufacturing facility at 400 Shire Way in Lexington, MA. The European Commission’s decision is expected imminently.
“We welcome the news that Shire’s new manufacturing facility in Lexington has received EMA approval for the production of VPRIV,” said Tanya Collin-Histed of the European Gaucher Alliance. “This provides patients with greater comfort over the maintenance of supply of enzyme therapies for the treatment of Gaucher disease.” Shire now has two EMA approved facilities – Alewife, in Cambridge, MA, as well as the new Lexington facility – in which to manufacture VPRIV drug substance. This additional capacity will allow Shire to significantly increase global supply of VPRIV and provides additional manufacturing flexibility. The EMA approval is also a critical first step in releasing further capacity for the manufacturing of REPLAGAL (agalsidase alfa) at Shire’s Alewife facility. The new facility increases bioreactor capacity from 1000 to 8000L, and is the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing to reduce manufacturing risk.
“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, 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.”