Shire plc announced that the U.S. Food & Drug Administration (FDA) has approved the production of VPRIV drug substance (velaglucerase alfa for injection) in Shire’s manufacturing facility at 400 Shire Way, Lexington, Mass. The facility was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.“FDA approval of Shire’s manufacturing facility in Lexington provides greater assurance that Gaucher patients will receive consistent and uninterrupted access to enzyme replacement therapy for the treatment of type 1 Gaucher disease,” said Rhonda Buyers, CEO and executive director, National Gaucher Foundation.
Shire has invested over $200M in manufacturing infrastructure and technology to establish a consistent drug supply chain to patients that use this treatment. The new facility is the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing designed to reduce manufacturing risk.
“Shire has always been committed to providing uninterrupted treatment for all VPRIV patients at the dose and frequency prescribed by their physicians. We continue to deliver on this commitment,” said Bill Ciambrone, executive vice president, technical operations, Shire.
Shire now has two FDA and EMA approved facilities in which to manufacture VPRIV drug substance- the Alewife and the Lexington facilities, both in Massachusetts.
Date: February 14, 2014
Source: Shire
Filed Under: Drug Discovery
