New plant-made vaccine wins first federal approval
Dow AgroSciences has won the first federal approval of a plant-made vaccine, the product of a laboratory process that avoids the controversial use of pharmaceutical field crops.
The chicken vaccine will not be commercialized, but officials with Dow AgroSciences said Tuesday that winning approval from the U.S. Agriculture Depart- ment's Center for Veterinary Biologics in Ames, Ia., showed the promise for making pharmaceuticals from plant cells, rather than animal products or whole plants.
"We felt it was extremely important to understand whether or not this technology platform could meet" the USDA's regulatory requirements, said Butch Mercer, the company's global business leader for animal health.
Dow's advance comes amid lingering concerns about using genetically engineered field crops, such as corn, to produce pharmaceuticals.
Iowa Gov. Tom Vilsack has been pushing the pharmaceutical corn production, but research in that area has slowed because of strong opposition from the food industry and a series of highly publicized mistakes by biotech companies. Food companies fear that pharmaceutical crops could contaminate ingredient supplies.
Dow AgroSciences, an Indianapolis-based unit of Dow Chemical Co., developed its vaccine by fermenting bioengineered tobacco cells in steel tanks.
The plant cells produce the antigens used to make the vaccine against Newcastle disease, a contagious and fatal viral disease affecting all species of birds.
Vaccines are typically made from chicken eggs or in mammalian cells, which can carry diseases. The Dow process also uses fragments of the virus, rather than the entire pathogen, in making the vaccine.
"It's inherently safer because you're not treating an animal with a virus," said John Cuffe, the company's research and development leader for animal health.
The plant-made vaccine also does not need cold storage.
Dow has several commercial products in development, all intended for animals. The first product is not expected to reach the market before 2009 or 2010. There are already several Newcastle vaccines on the market.
"Clearly, the advantage of all this is that it gets around the containment issue" involved in growing pharmaceutical plants outdoors, said Stephen Howell, director of Iowa State University's Plant Sciences Institute.
The laboratory process would be useful for making products that aren't needed in large quantities, Howell said.
Making a vaccine from the fermented tobacco cells requires only a fraction of the material needed for some drugs, such as digestive aids that would be made from corn.
Stephanie Childs, a spokeswoman for the Grocery Manufacturers of America, said the food industry welcomed finding methods of drug manufacturing that "maintain the purity of the food supply."
"Source":[ http://www.checkbiotech.org/root/index.cfm?fuseaction=news&doc_id=12154&start=1&control=228&page_start=1&page_nr=101&pg=1]