Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genzyme, a biotechnology company based in Cambridge, Massachusetts, has detected an impurity in one vial of Cerezyme, produced at its Irish manufacturing facility, located in Waterford.
Subscribe to our email newsletter
According to media reports, Genzyme discovered a chemical called 2,4 dichlorobenzoic acid (2,4 DBCA) in one Cerezyme vial during routine quality control checks at the facility, and has already notified FDA and European regulators of the contamination last month.
Genzyme was asked by the Australian regulators to notify Australian patients and doctors. Hence, it decided to inform the global patient population.
Genzyme said: “This impurity may have been present at very low levels in a very small percentage of Cerezyme vials (less than 1%). It has not been associated with any adverse effects in human beings and the level detected in the Cerezyme vial was 40,000 times lower than levels reported to cause harm in mice.
“Based on review of the medical literature and the Cerezyme safety database, any risk to patients from this impurity is considered to be remote. The Cerezyme batch in question meets all routine quality release standards and therefore has been released for use. The overall safety profile of Cerezyme remains unchanged.”
According to Lori Gorski, spokesperson of Genzyme, the source of 2, 4 DCBA, silicone tubing used during vial filling operations at the Waterford facility, has already been replaced with platinum tubing.
The biotechnology company said that after a review of the medical literature, it decided to release the batch of Cerezyme made in Ireland. The overall safety profile of Cerezyme remains unchanged, as said by the company officials.