Setback on road to recovery for Genzyme’s Allston facility
pharmafile | March 28, 2011 | News story | Manufacturing and Production |Â Â GenzymeÂ
Genzyme has been forced to discard one lot of its Fabry disease treatment Fabrazyme (agalsidase beta) manufactured at its troubled Allston Landing facility.
The news is a setback for the company, and a blow for Fabry disease patients around the world, whose access to Fabrazyme has been strictly rationed since Allston Landing was hit by viral contamination and other quality control problems in 2009.
In a statement, Genzyme said: “we have encountered some challenges with one particular step in the manufacturing process”, which led to one batch of Fabrazyme vials being scrapped because it did not meet release criteria.
“These challenges have occurred in the area of our Allston Landing … facility where some of the Fabrazyme we make is freeze-dried and put into vials – the “fill/finish” suite”, according to the company, which says it will now fill and finish all future lots of Fabrazyme at a contract manufacturing facility.
Since the beginning of 2010, contract manufacturer Hospira has been providing fill and finish activities for Fabrazyme and Gaucher disease treatment Cerezyme (imiglucerase), another Genzyme product affected by the Allston Landing problems.
“We have been operating with very limited inventory of Fabrazyme”, said Genzyme. “Because inventory is so limited, loss of this specific lot of Fabrazyme will have an impact on some patients in the coming months.”
The company, which is in the process of being bought by Sanofi-Aventis, sought to reassure patients and investors by saying it is still on track to re-establish normal supplies of Fabrazyme in the second half of this year, when its new manufacturing facility in Framingham, Massachusetts, is completed.
Thyrogen shortage in Europe
Meanwhile, Genzyme has informed the European Medicines Agency (EMA) that there may be a shortage of another of its products, Thyrogen (thyrotropin alfa), because of its ongoing manufacturing problems. Thyrogen is used to treat patients with thyroid cancer.
The EMA has been advised that a rationing system should be implemented. “Genzyme will only be able to supply Thyrogen to meet approximately 45% of EU demand through to July 2011”, said the agency. Thyrogen use should be restricted to those patients who are not able to tolerate thyroid hormone withdrawal, or in whom thyroid hormone withdrawal would not be effective.
Phil Taylor
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