With European approval, Shire ($SHPGY) is ready to start production at its new $200 million, energy efficient plant in Lexington, MA.
The EMA has given the biopharmaceutical company the green light to produce Vpriv, thus giving treatment options for Gaucher patients worldwide. Vpriv is a competitor to Cerezyme, which Genzyme has had to ration because of production issues at its own Massachusetts plant.
While it is not yet FDA-approved, increased capacity from the new facility will allow Shire to add to global supplies. It also produces Vpriv at its EMA-approved plant in Cambridge, MA. Shire's capacity will grow 8-fold, from 1,000L to 8,000L, with the new plant.
The plant, which took three years to build, will utilize single-use bioreactor and disposable technology in cell culture processing. The technology uses disposable bags instead of a culture vessel. In addition, Shire will use approximately 80% less water and 50% less electricity at the LEED-certified plant compared with a conventional facility, according to estimates.
The added capacity also permits Shire to open space for increased production of Replagal, a Fabry disease treatment that competes with Fabrazyme, another Genzyme drug in short supply. With FDA and EMA approval of its new plant in Framingham, MA, Genzyme, now owned by Sanofi ($SNY), has said it will produce more Fabrazyme.
- see the Shire release