Allston, we have a problem
Efforts by Genzyme Corp. to move past the manufacturing problems at its Allston, Mass. facility hit another stumbling block last week as FDA issued a warning letter about foreign particle contamination in five of Genzyme's marketed drugs.
In the notice to healthcare professionals, the agency said it was alerted to the particles, which are believed to be in less than 1% of products, through product quality reports submitted by Genzyme in May.
The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper and fiber-like material from the manufacturing process in five Genzyme drugs: Cerezyme imiglucerase for Gaucher's disease; Fabrazyme agalsidase beta for Fabry's disease; Myozyme alglucosidase alpha for Pompe's disease; Aldurazyme laronidase for mucopolysaccharidosis type I (MPS I); and Thyrogen thyrotropin alpha for thyroid cancer.
The FDA warning is just the latest in a series of manufacturing missteps that have plagued the biotech and left some patients and physicians in the lurch.
Some Gaucher's patients, for example, have been put on reduced doses of Cerezyme to cope with the drug's shortage related to a viral infection discovered at the plant in June.
The prolonged shortage has spurred public health agencies and clinician groups to turn to yet unapproved products. In the process, they are conducting what amounts to a public experiment in reducing the maintenance dose of Cerezyme for Gaucher's patients.
Patients and doctors also will be deciding whether to convert to yet unapproved treatment being made available during the shortage, which means they will have to decide whether to switch back to the Genzyme product.
Additionally, Genzyme has faced issues over a lack of consistency in the products produced in different Myozyme bioreactors, which has resulted in delayed approval for larger batches of the drug, leaving some Pompe's patients untreated.
In a statement last week, Genzyme said "the safety profile of these products remains unchanged. A review of the global safety database for these products has not identified any safety concerns to suggest that patients treated with Genzyme products have been exposed to foreign particles. However, a theoretical safety