Shire plc received approval from the FDA for the production of VPRIV drug substance (velaglucerase alfa for injection) at its manufacturing facility in Lexington, MA. The facility was previously approved by the EMA for production of VPRIV drug substance.
Shire has invested more than $200 million in manufacturing infrastructure and technology to establish a consistent drug supply chain for this treatment. The facility is the first commercially licensed facility to use 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.