The decontamination of a Boston-area Genzyme plant due to a virus in a bioreactor will take longer than expected, the company says, extending the rationing of the two drugs made there.
The extension is a result of expanding the cleanup. The company says more time is needed so virus-killing vaporized hydrogen peroxide can be dispersed throughout the plant's purification area and the cell-culture area, according to a Boston Globe report. "We've decided to sanitize the entire manufacturing facility, not just the cell-culture production area,'' says Genzyme spokeswoman Lori Gorski, in the Globe.
The plant is used to make Cerezyme and Fabrazyme, enzyme-replacement treatments for Gaucher disease and Fabry disease, respectively, as we reported last week.
Genzyme says it is following a "well-established and proven method" for removing the contaminant, Vesivirus 2117: disassembly and removal of equipment, cleaning, disinfection of cell culture and downstream production suites with vaporous hydrogen peroxide, installation of new air filters and insulation, and other measures. When sanitization is complete, equipment will be reassembled, tested and brought back into operation on a rolling basis. Genzyme says it will not be required to perform process validation runs.