Shire says new plant will add to Replagal, Vpriv capacity
pharmafile | January 17, 2011 | News story | Manufacturing and Production | Cerezyme, Replagal, Shire, Vpriv
UK drugmaker Shire has completed construction of a new manufacturing facility for its orphan disease drugs Replagal and Vpriv, and expects it to come online later this year.
The new large-scale facility in Massachusetts, USA, is expected to seek approval to make Fabry disease treatment Replagal (agalsidase alfa) later this year and Vpriv (velaglucerase alfa) for Gaucher disease in 2012, according to a Bloomberg report.
The 200,000 sq.ft. facility in Lexington has cost upwards of $250 million to set up and is claimed to be the largest bioprocessing facility in the world using disposable manufacturing equipment. In addition to cell culture production areas, the plant has a clinical suite and warehousing units.
Last year, Shire added to its presence in the city via a $165 million deal to acquire additional space on the Lexington Technology Park where its new plant is located. The firm is also building a $160 million R&D facility on the site.
Shire is hoping that the new manufacturing capacity will help it consolidate gains in the market for these rare diseases which have resulted from manufacturing problems at rival drugmaker Genzyme.
Genzyme is still experiencing shortages of Fabry disease treatment Fabrazyme (agalsidase beta) and Cerezyme (imiglucerase) for Gaucher disease because of contamination issues at its facility in Allston Landing. The company has been forced to move fill-and-finish activities away from Allston to other facilities in its manufacturing network.
The shortage of Cerezyme in particular prompted the FDA to accelerate approval of Vpriv, but Shire itself does not have sufficient capacity at present to meet demand among the Gaucher and Fabry disease patient community.
At the moment supplies of Replagal and Vpriv are being produced at Shire’s facility in Cambridge, Massachusetts.
Phil Taylor
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