Human health benefits from transgenic technology

Linda F. Benedict, Bogren, Richard C.

A new wound-care product that uses a growth factor to stimulate wound healing is the latest product stemming from protein-expression technology developed by LSU AgCenter researcher Richard Cooper.

The technology originated when Cooper, a microbiologist, developed a mechanism for transferring genetic material from one species to another using a string of DNA called a transposon. Cooper was then able to force incorporation of a transgenic gene into another organism. The benefits include stable integration of the new gene and a higher percentage of success.

The successful process resulted in a patented catfish. But the transgenic catfish couldn’t be grown commercially because of concerns it would escape into the wild. The only way transgenic, disease-resistant catfish could be raised commercially was to make them sterile – and that never happened.

So with the catfish success behind him, Cooper began applying the genetransfer technique to chickens to make human pharmaceutical proteins in egg whites.

In the case of chickens, the goal was to have transgenic animals produce proteins for use in pharmaceuticals at a fraction of the cost of production methods used in the biopharmaceutical industry, Cooper said. And because the eggs aren’t consumed and the birds are housed in pens, there’s little or no problem with concerns about transgenics.

Transgenic refers to any organism that’s altered by introducing foreign DNA molecules into it. Transgenesis is the use of genetic engineering technology to introduce foreign DNA into the genome of an animal so the cells, including the sperm and eggs, are genetically altered.

Biological therapeutic products – sometimes called biologics – comprise many products, including proteins, viruses, vaccines and blood components or derivatives. Therapeutic proteins include monoclonal antibodies, cytokines and growth factors.

Early success with transgenic chickens led to the formation of a biopharmaceutical manufacturing company – TransGenRx – which licensed two patents from the AgCenter. Since the company was founded in 2003, Cooper and his associates have received 11 new patents and have 12 other patents pending. The AgCenter has a 50 percent interest in each new patent, said Cooper, who also is president and chief science officer with TransGenRx.

Using cells from the chicken as a model for gene delivery, Cooper discovered an approach that caused protein expression rates to significantly increase. Although they planned to develop a system for increased production in the hens, the protein expression and secretion rates were so high in the cells, the researchers decided to pursue a cellbased system with which the FDA is more familiar, Cooper said.

That discovery in laboratory-based cell culture produced increased rates of protein expression to generate growth factor proteins intended for use in new human biopharmaceuticals. The pat ented processes allow TransGenRx to develop custom proteins to target processes like protein production and gene therapy into virtually any animal or cell culture system.

The growth factor product uses an air-brush-type technique that mixes the growth factor with skin stem cells from the patient – usually burn victims who have lost skin to their injury. By harvesting skin stem cells from a 1-inch square of skin and combining it with a growthfactor solution, physicians are able to treat a burn in a process that takes 1½ to two hours. Sprayed on burns, the solution will stimulate new skin to regrow in six days.

Along with developing the growthfactor solution, TransGenRx also refined and developed a spray system that’s portable and disposable. So instead of relying on a cumbersome device that only can be used in a sterile environment, the sprayer can be used in a variety of situations, including a remote military field hospital.

In addition to treating burns, the product has been used in a gel for treating skin abrasions.

“We have been able to formulate and stabilize the material and keep it bioactive,” Cooper said. “The big thing is it works. We retain over 98 percent biological activity.”

In another development, TransGenRx technology is being used in collaborative research conducted by three companies: Esperion Therapeutics, of Plymouth, Mich.; Cleveland (Ohio) Clinic; and Swiftwater Group consultants, of Philadelphia, Penn. The goal is to treat cardio-metabolic disease. Based on HDL, the body’s “good” cholesterol, the therapy is designed to mimic or enhance the function of HDL in managing and removing cholesterol and other fats from the bloodstream and plaque on artery walls.

TransGenRx is producing protein-based materials for the process. “Cleveland Clinic has finished animal tests, which performed better than we anticipated,” Cooper said.

“In terms of both costs and complexity, the development of proteinbased therapies requires broad expertise and targeted, advanced technology to be successful,” Cooper added. “At TransGenRx, our proprietary protein expression technology is uniquely suited to meet the key challenges in the production of therapeutic proteins.”

Rick Bogren is a professor and science writer with LSU AgCenter Communications.

(This article was published in the fall 2012 issue of Louisiana Agriculture magazine.)

1/12/2013 1:46:51 AM
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