CAMBRIDGE, Mass.—Genzyme Corp. announced June 16 that it has found a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility.
Therefore, Genzyme said it will temporarily interrupt bulk production at the plant in order to sanitize the facility. The company expects the plant to be fully operational by the end of July.
The virus strain, Vesivirus 2117, has not been shown to cause human infection, according to Genzyme. It is known to interfere with the growth of CHO cells used to produce biologic drugs and was likely introduced through a nutrient used in the manufacturing process.
Genzyme confirmed that this virus was the cause of declines in cell productivity at its Allston and Geel facilities in two previous instances in 2008.
Genzyme identified the virus at the Allston plant over the weekend of June 13. On June 15, the company submitted information to the U.S. Food and Drug Administration and the European Medicines Agency. The company also held a conference call with the FDA on June 15.
Genzyme found the virus using a highly specific assay it developed after standard tests were unable to identify the cause of the previous productivity declines. Genzyme said is adding steps to increase the robustness of its raw materials screening and viral removal processes.
As a result of the virus, current inventories for Cerezyme and Fabrazyme are not sufficient to meet projected global demand, according to Genzyme.
The timing and extent of the Cerezyme supply constraint is being clarified and will be communicated as soon as possible, Genzyme said in a news release. Cerezyme is an enzyme replacement therapy for type 1 Gaucher disease.
The company expects Fabrazyme supply constraints to occur for a limited period beginning in September. Fabrazyme is an enzyme replacement therapy for Fabry disease, which causes extreme pain, inability to sweat, gastrointestinal problems and eventually kidney failure, heart attacks and strokes.
The company said it will work with physicians, patients and regulators to minimize the impact of this constraint. With regulatory input, Genzyme said it is finalizing its action plan and assessing the business impact of this situation. The company added that it will provide updated financial guidance as soon as possible.
“The patients who need these therapies are our priority,” said Henri A. Termeer, Genzyme’s chairman and CEO. “We are confident in the quality of the products produced in Allston and in our ability to resolve the issue affecting the plant. The impact will be temporary.”
