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Shire Files for Facility Approval

New facility to manufacture VPRIV

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Shire plc has submitted regulatory filings with the EMA and FDA for the production of VPRIV (velaglucerase alfa) at its manufacturing facility in Lexington, MA. Subject to regulatory approval, the company expects the new plant to significantly increase manufacturing capacity and allow for increased global supply of VPRIV. These approvals would also allow for increased capacity for the manufacture of Replagal (agalsidase alfa) at Shire’s Alewife facility, where both VPRIV and Replagal are currently manufactured.

“Shire remains committed to meeting the unique needs of patients living with rare diseases,” said Bill Ciambrone, senior vice president, Technical Operations, Shire HGT. “Accelerating the completion of our new manufacturing facility in Lexington will enable us to provide substantial additional capacity for VPRIV less than two years after launch. 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.”

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