Manufacturing changes extend Genzyme’s Fabrazyme shortage
Changes to manufacturing practices at Genzyme’s plant have led to further shortages of Fabrazyme (agalsidase beta), with production expected to remain below 30 per cent of demand until after June 30.
Genzyme has been improving quality systems at its plant in Allston Landing, Massachusetts, US but this has affected manufacturing timelines and bioreactor productivity. Furthermore, it took longer than expected to restart some operations following the temporary shutdown of the plant.
These issues were detailed in a letter to patients, reported in the Boston Business Journal, which extended the date for increasing production above 30 per cent of demand from April to after June 30.