Shire plc, the global specialty biopharmaceutical company, has received the US Food & Drug Administration (FDA) approval for the production of Vpriv drug substance (velaglucerase alfa for injection) in its manufacturing facility at 400 Shire Way, Lexington, Massachusetts, US. 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 $200 million in manufacturing infrastructure and technology to establish a consistent drug supply chain to patients that use this treatment. The 400 Shire Way 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, US.
In keeping with Shire's corporate sustainability commitments, the 400 Shire Way manufacturing plant has met the requirements for Leadership in Energy and Environmental Design (LEED) Certification and received formal recognition from the United States Green Building Council in Q1 2012. In addition to increasing capacity and reducing manufacturing risk, utilization of single-use technology at 400 Shire Way requires approximately 80% less water and 50% less energy than a conventional manufacturing plant.
Vpriv is made in a human cell line using Shire's gene activation technology. The enzyme produced has the exact human amino acid sequence as that found in the naturally occurring human enzyme. Vpriv is used for the long-term treatment of patients with type 1 Gaucher disease.
Vpriv is approved in over 40 countries globally, including the US, the European Union member states, and Israel, and is for patients previously treated for type 1 Gaucher disease or those who are treatment-naive.