This is a little different as we all read about computer viruses so much, but this is a real contamination issue. The plant had issues back in 2008 with a warning letter from the FDA. The plant makes drugs that treat enzyme deficiencies, so it is a small amount of the population that is affected. With all the recent food issues of late, it does make you wonder have these issues always somewhat been around or are we just better at detecting and finding them, well sometimes that is. BD
Over the weekend, drugmaker Genzyme shut down a Massachusetts factory after a virus infected hamster ovary cells used to produce Fabrazyme and Cerezyme, drugs for two rare genetic disorders.
Genzyme is the sole supplier of the medicines in the United States. When stocks of the medicines run low in August, patients may have to ration supplies for four to six weeks. Jack Johnson, a 46-year-old Missourian, who takes Fabrazyme, says the shutdown “is a concern for patients . . . but we’ll just have to wait and see how this all plays out.”
The U.S. Food and Drug Administration (FDA) has put shipments of Cerezyme and Fabrazyme on hold while the company conducts DNA tests on its current stockpiles, Genzyme Executive Vice President David Meeker said during a conference call yesterday. He expects the plant to reopen by the end of July, and supplies to be steady by the end of the year.
This was the second time the company’s production vats have been infected with a virus called Vesivirus 2117, which first hit its facilities in 2008. In February, the FDA also sent a warning letter to the plant after an inspection uncovered quality problems. However, company representatives said that Genzyme had already addressed the FDA’s concerns in that letter and that they were not linked to the viral infection, which was caused by contamination in a still-unidentified nutrient added to the cell mixture. “Contamination may be transient and we may never identify the source,” Meeker said.
Virus hits Genzyme plant, halting production of orphan drugs: Scientific American Blog
0 comments :
Post a Comment