But that's too "conspiratorial," right?
"virus is not considered harmful to humans....
the virus is not harmful to humans....
virus is not believed harmful to humans, Genzyme decided to undertake a massive decontamination effort as a precaution"
WTF, MSM?
"viral contamination in biotech manufacturing is not unheard of, [but] most cases don’t become public....
This type of thing happens commonly in the industry....
viral contamination takes place occasionally, but such problems are seldom publicly disclosed....
It’s a very common problem to have in biomanufacturing plants....
a one-time event.... "
???? Well, WHICH the F*** is it, and WOULD THEY TELL US?
Of course, MSM, government, and self-serving industries would never lie to you, right, America? Especially when a buck is at stake.
"Virus shuts Genzyme plant, holds up drugs for 8,000" by Erin Ailworth and Robert Weisman, Globe Staff | June 17, 2009
In an unprecedented move for Genzyme Corp., the state’s largest biotechnology company has halted production of two drugs for rare genetic disorders after a virus was discovered in production equipment at its Allston plant.
The drugs are used by 8,000 people worldwide and cost about $200,000 per patient annually. While the virus has the ability to taint the drugs, it is not considered harmful to humans, officials said. The manufacturing plant will remain shut through July while it is decontaminated as a precaution.
Shipments of the drugs, Cerezyme and Fabrazyme, have been put on hold while the US Food and Drug Administration seeks assurance from the company that none of its inventory is compromised. Genzyme officials believe the inventory was not affected....
Last fall, an FDA inspection of the Allston plant found “significant deviations from current good manufacturing practice in the manufacture of licensed therapeutic drug products, bulk drug substances, and drug components,’’ according to a warning letter sent to Henri Termeer, the company’s chief executive, on Feb. 27. Christopher C. Kelly, an FDA spokesman, would not say whether the deviations cited in the letter were related to the latest problem.
“Everybody has contamination issues in biotechnology, but contamination with a virus is rare,’’ said chemical engineering professor Carl W. Lawton, director of the Massachusetts Biomanufacturing Center at the University of Massachusetts at Lowell.... The incident reinforces the need for continued vigilance in the biotech manufacturing process, industry watchers said. Unlike traditional chemical-based drug production, they said, even slight changes in temperature or pH, a measure of acidity, can affect a biotech treatment.
They never tell us that when they say how much they are going to save the economy!
While viral contamination in biotech manufacturing is not unheard of, most cases don’t become public because drug makers have multiple supply lines, according to industry watchers. In this case, they said, Genzyme was compelled to announce the contamination because it disrupted the supply of drugs....
Regardless, the incident will affect Genzyme’s business - at least temporarily. The company’s shares tumbled. Stock analysts said the manufacturing interruption in Allston potentially could cost Genzyme $200 million to $300 million in lost revenue.
Keep that in mind for later.
Last year, Cerezyme - Genzyme’s biggest moneymaker - generated $1.24 billion in revenue, said spokesman Bo Piela. Fabrazyme brought in $494 million. Overall, Genzyme last year earned $421.1 million on revenue of $4.6 billion. John L. Sullivan, research director at Leerink Swann LLC, a Boston investment bank specializing in healthcare and life sciences, said he doubted the contamination incident will hurt Genzyme’s reputation or finances over the long term. He cited the company’s quick response to the virus and noted that the Allston plant manufactures products that have little competition.
--more--"
Related: The Needs of Genzyme Outweigh the Needs of All
Genzyme Corp. said yesterday it still believes the virus that shut down its biotechnology drug manufacturing plant in Allston came from tainted nutrients received from an outside vendor, raising the possibility that the virus could infect other companies that use the same supplier.
But Genzyme, based in Cambridge, said it hasn’t identified which vendor might be responsible for the contaminated supplies, making it difficult to determine how many other companies could potentially be affected. It is also unclear whether the ingredient is unique to Genzyme or is a common component in mixtures sold to other biotech companies.
“It’s a risk that is fairly impossible to evaluate,’’ Mark Trusheim, president of Co-Bio Consulting LLC, a biotechnology consulting firm in Acton, said of the potential for contamination elsewhere. “You can’t tell, given the information available.’’
Meanwhile, the Food and Drug Administration, which is responsible for inspecting drug manufacturing plants, said it is still investigating the Genzyme shutdown, which is expected to last through July while the plant is decontaminated. The agency hasn’t revealed any steps to prevent the virus from spreading elsewhere....
If the virus spreads to other biotech manufacturing plants, it could potentially force those companies to shut down their production lines. “It’s a likely scenario,’’ said Carl W. Lawton, director of the Massachusetts BioManufacturing Center at the University of Massachusetts at Lowell. “If one company has a viral infection [in its supplies], it is probably going to affect several different companies.’’
But Lawton said it may be less serious for companies that have adequate stockpiles of drugs on hand. Several biotech companies in the region said they believe they have procedures in place to detect any contamination problems before they become serious. Amgen Inc., one of the country’s largest biotechnology companies, said it has stringent quality control procedures to “catch potential problems early’’ at its manufacturing plant in Rhode Island.
Related: The Healthy and Hearty Voice of the Healthcare Lobbyists
Amgen spokesman Larry Bernard said the company needs to take precautions because “events like this can occur in the industry,’’ due to the complexities of manufacturing drugs using living cells. Wyeth, a drug company with a major biotech manufacturing center in Andover, said it also has procedures in place to “minimize the possibility of this type of event.’’
Genzyme spokesman Bo Piela said: “This type of thing happens commonly in the industry.’’
The Biotechnology Industry Organization, the national trade group that represents Genzyme and other biotech companies, declined to comment. But the organization’s Statement of Ethical Principles does not appear to address the situation.
--more--""After a virus invades, Genzyme scrubs down; Contamination cleanup halts weeks of genetic disorder drugs' production" by Robert Weisman, Globe Staff | June 25, 2009
The virus hunters have arrived at Genzyme Corp.
Dozens of decontamination specialists are busy stripping insulation from pipes at the company’s biotech drug plant overlooking the Charles River in Allston. Their prep work involves dismantling equipment, peeling gaskets from the lids of 2,000-liter vats called bioreactors, and scrubbing down every surface in sight with spore-killing bleach.
When everything is ready, they will wheel in the “vaporizers.’’ The squat machines, which look like industrial versions of the Star Wars robot R2-D2, will disperse clouds of vaporized hydrogen peroxide throughout the 185,000-square-foot production area. But first, the workers will be evacuated.
“It kills all known living things,’’ said Mark R. Bamforth, senior vice president for corporate operations at Cambridge-based Genzyme. The intensive cleanup follows the discovery of a virus in one of six bioreactors at the red-brick plant, which makes two expensive drugs to treat rare genetic disorders. Although the virus is not harmful to humans, it could affect the growth of cells used to make the treatments, Cerezyme and Fabrazyme, so production was halted almost two weeks ago.
Company officials won’t disclose how much they are spending on the cleanup, which is being performed by workers from a Pennsylvania decontamination contractor, but supervised by Genzyme engineers. Genzyme said it is looking toward a “rolling restart’’ of the Allston Landing plant in July, with all operations resuming by the end the month.
“At the end of this process, this whole facility will be disinfected,’’ Bamforth promised as he watched the cleanup operation in progress from a glassed-in viewing gallery. “We want to be sure we’ve eradicated the virus so future production won’t be affected.’’
Genzyme executives aren’t the only ones paying attention. This is the third time in the past nine months that the virus strain, called Vesivirus 2117, has been detected at a Genzyme manufacturing site. The first time was in September at a plant in Geel, Belgium, and the second incident occurred in November in Allston. The problem is being watched by the Food and Drug Administration....
Genzyme and some outside biotech manufacturing specialists said viral contamination takes place occasionally, forcing companies to undertake the kind of decontamination process Genzyme has begun, but such problems are seldom publicly disclosed....
“It’s a very common problem to have in biomanufacturing plants,’’ said Maik Klasen, senior director of the healthcare and life sciences consulting group at Frost & Sullivan, a market research firm in San Francisco....
--more--""Genzyme drugs could be rationed for longer" by Robert Weisman, Globe Staff | June 26, 2009
Mark Schoenebaum, senior biotechnology analyst at Deutsche Bank, yesterday boosted his forecast of Genzyme’s revenue shortfall stemming from the virus to $245 million, up from an earlier forecast of $100 million....
Again, remember that.
“This is the most important issue going on for Genzyme right now,’’ said Schoenebaum, who was conferring with company officials at the Allston plant yesterday. “They seem to be doing everything they can. If they can get it fixed, it would be a one-time event.’’
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"Cerezyme, an enzyme replacement therapy, is Genzyme’s biggest-selling product and, at $200,000 a year, is one of the world’s most expensive drugs. Cerezyme and Fabrazyme represented about 37 percent of the company’s 2008 revenue of $4.6 billion.
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Seeing what is important ($$$$), right?
"Patients OK as Genzyme cleans up drug facility" by Erin Ailworth, Globe Staff | July 10, 2009
Genzyme shut down its Allston production plant last month after it found a virus had contaminated a piece of equipment used to make the drugs. Although the virus is not believed harmful to humans, Genzyme decided to undertake a massive decontamination effort as a precaution.
--more--"
And about that economic hit:
"Genzyme's profit more than doubles
Genzyme Corp.’s second-quarter profit more than doubled, mainly on lower charges and research and development expenses, but the Cambridge company slashed its outlook because of production issues. The company said it earned $192.2 million (AP)."
What about the VIRUS and CLEAN-UP? Haven't heard much about that the last month, have you?
