Genzyme addresses impurity problem at Ireland Cerezyme plant

By Staff Reporter

- Last updated on GMT

Related tags: Gaucher's disease, Medicine

US drugmaker Genzyme has detected an impurity in one vial of the Gaucher’s disease drug Cerezyme produced at its manufacturing facility in Waterford, Ireland.

According to media reports Genzyme found a chemical called 2,4 dichlorobenzoic acid (2,4 DBCA) in one Cerezyme vial during a routine inspection last month and has already notified regulatory authorities and patients.

In a statement on its website Genzyme said that: “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​.”

These comments were reiterated by company spokesperson Lori Gorski who told the Boston Globe​ yesterday that very low levels of the impurity had been detected in one Cerezyme vial and stressed that: “This is not a safety risk​.”

She went on to explain that the source of 2, 4 DCBA, silicone tubing used during vial filling operations at the Waterford facility, has already been replaced with platinum tubing.

Josh Schimmer, managing director at the health care investment bank Leerink Swann LLC, told the paper that the incident is “pretty minor’’​ and that it is unlikely to disrupt supply.

The speed of response indicates that Genyme is keen to avoid any of the criticisms it faced​ after finding viral contamination at its plant in Allston in the US and, more recently​, the discovery of plastic and rubber fragments in certain batches of key products.

The firm will also be relieved that the supply of Cerezyme will not be disrupted by the latest issue given the market opportunity​ last year’s shortages gave rival Gaucher’s disease treatment developers Shire, Pfizer and Protalix.

Related topics: Contract Manufacturing & Logistics

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