Genzyme needs to clean up its act--again. The FDA has notified the company of new problems at its main plant in Allstons Landing, MA, which was shut down for decontamination in June. The company has been laboring to fix manufacturing deficiencies FDA identified during a May visit, hoping to get the all-clear. But during a lengthy inspection that wrapped up Friday, the agency found more problems centered on its "fill/finish" operations.
The deficiencies in Genzyme's won't affect the plant's ability to produce its biologic drugs, most of which are used to treat rare diseases. And, the company said, the problems won't affect the planned delivery of Gaucher disease treatment Cerezyme, which is scheduled to finally start shipping again in late November. They may, however, delay the planned re-release of Fabry disease drug Fabrazyme.
They've already thrown a wrench into the approval of Lumizyme, the large-batch version of Pompe disease drug Myozyme. Indeed, the company disclosed the Allston plant's latest troubles in a press release about the FDA's delaying its Lumizyme review. The agency wants the Allston plant completely trouble-free before it will take another look at approval.
Genzyme says the fill/finish troubles at Allston stem from aging equipment used in that process. So while it works to update the Allston facility--and impose new internal controls there--it plans to move some filling work to contract manufacturers and to use excess capacity at a Genzyme plant in Waterford, Ireland, Dow Jones reports. "We have made significant progress in bringing the Allston plant back in operation," CEO Henri Termeer said in a statement, "and we will continue to work closely with the FDA to resolve these issues." Stay tuned.