Genzyme detected a virus that impairs cell growth in one of six bioreactors at its Allston Landing, MA, manufacturing facility. The company has thus decided to stop bulk manufacturing while the plant is sanitized. 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. 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, the firm explains.
Current inventories for Cerezyme® (for Gaucher disease) and Fabrazyme® (for Fabry disease) are not sufficient to meet projected global demand. Genzyme is currently working to clarify the timing and extent of the Cerezyme supply constraint. The firm expects Fabrazyme supply constraints to occur for a limited period beginning in September.
The 185,000-sq-ft facility at Allston has a manufacturing capacity of 12,000 liters. Production of Myozyme (for Pompe disease) is also undertaken here, but is reportedly not affected.
Genzyme also confirmed that this virus was the cause of declines in cell productivity at its Allston and Geel, Belgium, facilities in two previous instances in 2008, which were subsequently fully addressed. The firm 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 reports that it is adding steps to increase the robustness of its raw materials screening and viral removal processes.