The manufacturing plant was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.
National Gaucher Foundation CEO and executive director Rhonda Buyers said, "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."
In order to establish a consistent drug supply chain to patients those use this treatment, the company has invested over $200m in manufacturing infrastructure and technology.
According to the company, the 400 Shire Way manufacturing 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 executive vice president of technical operations Bill Ciambrone said, "Shire has always been committed to providing uninterrupted treatment for all VPRIV patients at the dose and frequency prescribed by their physicians."
Currently, the company has two FDA and EMA approved facilities in which to manufacture VPRIV drug substance – the Alewife and the Lexington facilities, both in Massachusetts, US.