Genzyme’s Troubled Allston Plant Resumes Drug Shipments

Genzyme’s troubled Allston, Mass., facility is shipping new Cerezyme vials and preparing to release new Fabrazyme lots.

The plant has recently dealt with two GMP issues — a viral contamination earlier this year that led to a plant shutdown and fill-finish deviations last month that led to particulate contamination. These issues were cited in a November complete response letter for Pompe disease treatment Lumizyme (alglucosidase alfa).

Genzyme says it plans a resubmission to the FDA after agreeing on an approval pathway with the agency.
Drug GMP Report