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Genzyme Corp. is in the middle of a whodunit mystery. The company is trying to track down the origin of a virus that shut down its biologics manufacturing facility in Allston, disrupted the supply of two drugs for rare diseases, and forced the company to ramp down its revenue projections by hundreds of millions of dollars.
The Cambridge-based maker of treatments for Fabry disease and Gaucher’s disease is ready to reopen the plant after a decontamination process that lasted six weeks and, analysts say, likely cost upwards of $10 million. It will then take about four months, from start to finish, to produce more medicine.
It was the company, not the U.S. Food and Drug Administration, that located the virus and shut down the plant, and it will likely be Genzyme, and the biologics community at large, who figure out where the virus came from. The case illustrates not just the complexity of making a drug from living organisms, but the tremendous challenge in regulating those processes.
The shutdown was the culmination of months of detective work by the company, following an unexplained drop in cell productivity in one of the bioreactors. Tests required by the FDA found nothing amiss.
Genzyme eventually sequenced the virus, called Vesivirus 2117 and developed a test to screen for it. The virus doesn’t harm humans, but could make drugs less potent, compromising patient treatment.
“The virus was found in different bioreactors, at two different facilities, and in two different drugs. We determined it had to be a raw material that was used in all those processes,” said Genzyme’s senior vice president for corporate operations and pharmaceuticals, Mark Bamforth.
Genzyme officials say that since announcing the shutdown, biotech companies from across the country have come forward to acknowledge, “Yes, we had a virus, too.”
Most of the companies were not forced to disclose their own virus contaminations publicly because, unlike Genzyme, they had enough stockpile of their drugs to avoid a disruption to the supply. Genzyme has offered to share its Vesivirus 2117 test with other companies that suspect they may have a virus. Genzyme is now going through the process of contacting all of its vendors to try to find the source of the virus that hit its Allston plant.
The question is whether the FDA will add Genzyme’s test for Vesivirus 2117, or tests for other viruses, to its existing battery of screens for biologics manufacturing. “When it comes to biologics, the FDA is always seeking more effective tools to improve its manufacturing regulations,” said former FDA associate commissioner for external relations Peter Pitts. Current FDA officials did not respond to requests for an interview.
But other analysts wonder how many tests the FDA can realistically require. “It’s too much to expect the FDA to keep up with all we are going to learn about biologics in the next few years,” said Bill Mackin, the head of regulatory affairs at Lexington-based Aptuit Consulting. Mackin said the industry will often have the responsibility for regulating itself.
But some analysts say this case is a warning — if a virus can trigger a shutdown at Genzyme, it can happen anywhere. Mark Trusheim, president of Acton-based Co-Bio Consulting, said, “The process worked this time. But the real challenge comes if generic versions of biologics are approved. The pressure to cut costs will force more manufacturing overseas, where quality controls in some countries may not be as tight.”
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