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news.Shire has received the European Medicines Agency (EMA) approval for the purification of Replagal (agalsidase alfa) drug substance at its new manufacturing facility in Lexington, US.
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Replagal is an enzyme replacement therapy for the treatment of Fabry disease.
With this approval, the company now has two approved facilities, Alewife, and the new Lexington facility, in which the company will purify Replagal.
The cell culture portion of the Replagal manufacturing process will continue to be conducted at Alewife.
Shire HGT Technical Operations senior vice president Bill Ciambrone said they are pleased that they were able to accelerate the construction and approval of their new manufacturing facility in order to provide access to important therapies for patients in need.
Shire anticipates regulatory agency submission of the VPRIV (velaglucerase alfa) manufacturing process at the new Lexington manufacturing facility by the end of 2011.