Cerezyme, Fabrazyme Shortage Fears After Genzyme Suspends Production Over Viral ContaminationJun 16, 2009 | Parker Waichman LLP
Production at a Genzyme drug manufacturing plant in Massachusetts has been temporarily suspended because of viral contamination. There are fears that the shut-down could cause shortages of the drugs Cerezyme and Fabrazyme, which are used to treat rare genetic disorders.
According to a Genzyme press release, the virus Vesivirus 2117 has been detected in one of six bioreactors at its Allston Landing manufacturing facility. This virus has not been shown to cause human infection, but it is known to interfere with the growth of CHO cells used to produce biologic drugs. Genzyme said it was likely introduced through a nutrient used in the manufacturing process.
Genzyme said it has now confirmed that this virus was the cause of declines in cell productivity at its Allston and Geel facilities in two previous instances in 2008, which were subsequently fully addressed. The company was able to detect the virus in this case using a highly specific assay it developed after standard tests were unable to identify the cause of the previous productivity declines. Genzyme said it is adding steps to increase the robustness of its raw materials screening and viral removal processes.
The Allston Landing plant is the only one where Genzyme produces Cerezyme and Fabrazyme. Cerezyme is used to treat Gaucher disease, while Fabrazyme is a therapy for Fabry disease. According to Genzyme, the shutdown could impact supplies the two drugs. The company's press release said that current inventories are not sufficient to meet projected global demand. The timing and extent of the Cerezyme supply constraint is being clarified and will be communicated as soon as possible. The company expects Fabrazyme supply constraints to occur for a limited period beginning in September. Genzyme said it will work with physicians, patients and regulators to minimize the impact of this constraint.
Genzyme identified the virus at the Allston Landing plant over the weekend. The company submitted information to the Food & Drug Administration (FDA) yesterday afternoon. It is collaborating with the agency as it works to resume production, which according to the press release, should occur sometime in July.
According to Reuters.com, the Allston Landing facility was the subject of a FDA warning letter that followed an inspection in September and October. One of the FDA's concerns was controls to protect against microbial contamination, Reuters said.