EMA approves new manufacturing facility for Shire’s REPLAGAL
Company now has two approved facilities in which to purify enzyme replacement therapy product
The European Medicines Agency (EMA) has approved the purification of Shire’s REPLAGAL (agalsidase alfa) drug substance at its new manufacturing facility in Lexington, Massachusetts, US. Shire’s enzyme replacement therapy for the treatment of Fabry disease is the first product that will be made available to patients from the new facility.
With this approval, the company now has two approved facilities – Alewife, which is located in Cambridge, MA, as well as the new Lexington facility – in which to purify REPLAGAL, thus providing increased manufacturing flexibility. The cell culture portion of the REPLAGAL manufacturing process will continue to be conducted at Alewife.
‘We are pleased that we were able to accelerate the construction and approval of our new manufacturing facility to provide rapid access to important therapies,’ said Bill Ciambrone, senior vice president of technical operations, Shire HGT. ‘This new facility allows greater flexibility to meet global demand for our products, including REPLAGAL.’
In addition to REPLAGAL, Shire expects regulatory agency submission of the VPRIV (velaglucerase alfa) manufacturing process at the new Lexington manufacturing facility by the end of 2011.