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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use has approved the production of VPRIV (velaglucerase alfa) in Shire's new manufacturing facility at 400 Shire Way in Lexington, Massachusetts, US.
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The additional capacity is expected to increase global supply of VPRIV and provides additional manufacturing flexibility.
According to the company, the 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.
Shire HGT technical operations senior vice president Bill Ciambrone said the EMA approval of VPRIV in the manufacturing plant, only three years after breaking ground, is a testament to the hard work and dedication of Shire employees.
"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," Ciambrone added.