Genzyme plays down Irish contamination
pharmafile | March 18, 2010 | News story | Manufacturing and Production |Â Â Cerezyme, Contamination, Fabrazyme, GenzymeÂ
The contamination problems plaguing Genzyme in the US have also appeared in product manufactured at its plant in Waterford, Ireland, although the firm insists the latest case has already been set right.
The US biotechnology company has been hit hard by a string of contamination issues that have hit at its ability to supply some of its top-selling products, including Cerezyme (imiglucerase) for the rare genetic disorder Gaucher disease.
In the latest incident the contamination, which was seen in one vial of Cerezyme from a single production batch, was traced to silicon tubing used for vial-filling at the plant.
The contaminant – 2,4 dichlorobenzoic acid or DCBA – is known as a leachable compound that can be present in some grades of silicon tubing, particularly tubing that is ‘cured’ using a peroxide-based process.
Genzyme says it has now replaced the material with platinum-cured tubing to avoid leaching of contaminants into the finished product. DCBA may have been present in around 1% of the Cerezyme vials in very low concentrations, 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,” said the company in a statement.
Genzyme faced major production challenges at its manufacturing facility in Allston Landing, USA last year, relating to regulatory compliance issues and an unrelated problem with a viral contaminant in the facility’s bioreactors that forced a shutdown for several weeks and interrupted production of Cerezyme and Fabry disease drug Fabrazyme (agalsidase beta).
That was followed later in 2009 by cases of contamination with foreign particles such as rubber and stainless steel fragments in Thyrogen and another product, (laronidase) for mucopolysaccharidosis type I made at the same facility.
The swift resolution of the issue is a boost for Genzyme, particularly as it has been recovering from Cerezyme supply issues by boosting production at other locations, including Waterford.
The company has invested more than 400 million euros in the Irish facility since it was first opened in 2001, and is currently coming to the end of an expansion programme that will boost the capacity of its fill-and-finish facility, expand quality control laboratories and add new production lines for solid oral dosage forms.
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