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Which came first? New insulin source

Richard Cooper, a microbiologist in the LSU AgCenter's Department of Veterinary Science, said that in early work with quail, the birds not only produce proteins in their eggs but pass the traits on to subsequent generations.

"This has the potential for revolutionizing the way pharmaceuticals are produced," Cooper said. He said the process involves the way genes are put into animals to benefit human medicine.

"The procedures developed with quail are directly applicable to chickens," Cooper said. "These transgenic chickens can produce pharmaceutical-grade protein drugs such as insulin and growth hormone for a fraction of the cost of processes currently used."

Cooper said with more than 100 protein-based pharmaceuticals in various stages of clinical trials, the drug industry needs production methods more economical than the current ones involving facilities costing from $250 million to $500 million each.

The LSU AgCenter scientist's process is based on patented and patent-pending procedures he developed using what he termed a "vector" that introduces specific genes into poultry.

"The transgenic poultry then produce proteins for use in pharmaceuticals at a fraction of the cost of production methods used in the bio-pharmaceutical industry," Cooper said.

The LSU AgCenter and Cooper have the patents and have licensed them to TransGenRes LLC (TGR), a biological manufacturing company.

Cost has been the single greatest obstacle faced by pharmaceutical firms and related industries that use proteins and biologics in health care as well as in industrial applications, said Bill Fioretti, a biochemist and president of TGR.

During Monday's announcements, Fioretti called Cooper's technology "the most significant biotech breakthrough in two decades." He said the process "allows us to produce human protein drugs – essentially any protein of value – in the eggs of chickens."

The Louisiana Economic Development Corp. provided a grant of $2.5 million to purchase equipment and expand the facilities on the LSU AgCenter campus in Baton Rouge that are currently being leased to TGR for its initial operations.

"This is truly an exciting day for our state," said Don Hutchinson, secretary of Louisiana Economic Development. "It can mean jobs for people of our state. We can compete in the biotech area; we can compete in the science area."

Fioretti said TGR will be a Louisiana company.

"Our goal is to be a world leader in the production of protein drugs and be based in Louisiana," Fioretti said. "This investment will return significant benefit to the taxpayers of Louisiana."

Calling it "a scalable, expandable process to maximize productivity," Fioretti said the process is "rapid-expression technology that will produce protein drugs at a fraction of the cost of current production methods."

The net result will be a huge benefit to both consumers and the pharmaceutical industry, he said.

"With the decoding of the human genome, demand for proteins worldwide has increased exponentially while production capacity has been falling farther behind," Fioretti said. Industry estimates put the shortfall at more than a million grams by 2006.

Fioretti said current production of protein pharmaceuticals typically depends on manufacturing processes that use bacterial fermentation and mammalian cell culture. "Costs of protein production using bio-fermentation can range from several hundred to several thousand dollars per gram," he said.

The TGR president said the LSU AgCenter technologies and methods can significantly lower production costs and increase production efficiency.

"Thousands of pharmaceutical proteins can be developed in laboratories, but researchers can't afford the next step," Cooper said. "This technology can reduce the cost of the next step."

Cooper's technology starts by injecting a rooster with a specific DNA and mating it with a hen. Scientists screen the offspring for the desired protein-producing trait and cross the offspring to produce subsequent generations that carry the trait in both males and females.

"After that, flock size can be adjusted as needed to meet demand," Cooper said.

"The transgenic production of human protein drugs using a chicken as a bio-reactor in no way harms the chicken," Fioretti said. "Basically, all we have to do is feed the chickens and collect their eggs."

TGR has leased production facilities in Wilson Hall on the LSU campus and on the LSU AgCenter's Central Research Station in Baton Rouge to begin initial production of the proteins.

The company estimates that by the end of 2009, it will have invested $100 million and will employ more than 500 people in well-paying technology jobs in Louisiana.

Company officials said the poultry used in this process can be raised and handled using accredited animal care guidelines and laboratory practices established by the U.S. Food and Drug Administration. When the eggs are laid and collected, TGR will extract the proteins and ship them to pharmaceutical companies for final purification and processing into drugs.

Rick Bogren is a writer for the LSU AgCenter.


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