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Genzyme Corporation has halted production at its manufacturing plant in Allston Landing, MA, because it has detected a virus that impairs cell growth in one of the six bioreactors there.
Genzyme Corporation has halted production at its manufacturing plant in Allston Landing, MA, because it has detected a virus that impairs cell growth in one of the six bioreactors there, the company announced yesterday. The company will sanitize and fumigate the facility, and expects to resume production by the end of July.
The virus strain, Vesivirus 2117, is known to interfere with the growth of Chinese hamster ovary (CHO) cells and is believed to have been introduced through a cell culture nutrient. Genzyme confirmed that this virus was the cause of declines in cell productivity last year at its facilities in Allston and Geel, Belgium, which were subsequently addressed.
The company was able to detect the virus in this case using a PCR assay it developed after standard tests were unable to identify the cause of the previous productivity declines. Genzyme has added this assay to its standard screening.
The virus, a member of the calicivirus family, has not been shown to cause human infection, and the company was unable to infect any of three human cell lines that it tested. Nonetheless, the US Food and Drug Administration has asked the company to run the assay on finished lots. The company is also in contact with the EMEA and other regulatory authorities around the world.
Unrelated to Recent Warning Letters
During a conference call, Alison Lawton, vice president of global market access, said the current shutdown was unrelated to the previous FDA warning letter for the Allston plant, and would not be a barrier to FDA approval of Lumizyme.
Following the reinspection of the Allston facility, Lawton said, the FDA inspector concluded that the company had satisfactorily addressed all of the items in the warning letter, dated February 27. In addition to addressing questions about the comparability of the drug produced at different scales, the company had to resolve the manufacturing compliance concerns raised in the February warning letter before Lumizyme could be approved.