Researchers may have created a purer, safer fully synthetic heparin as an alternative to the commonly used blood thinner, according to Robert J. Lindhardt, scientist and professor at the Rensselaer Polytechnic Institute in Troy, N.Y.
At the national conference of the American Chemical Society (ACS) on Aug. 17, Linhardt said that the synthetic creation is the largest dose of heparin ever created in the lab. Heparin is commonly derived from the intestines of foreign livestock and the risk of contamination from such sources is high, he said. So far, the synthetic heparin has been created on a tiny scale, using one-liter fermenters, reported The Philadelphia Inquirer.
As Linhardt and others worked toward an alternative, drug manufacturers worked to eliminate the risk of contamination, but the risks proved too high, Linhardt said. In February, the search for a safer alternative reached a frantic pace after more than 80 people globally died and hundreds became ill after they were administered what was believed to be contaminated batches of heparin.
Linhardt was on the international team that identified the suspected contaminant in the Chinese heparin, a structurally similar carbohydrate called oversulfated chondroitin sulfate.
"When we found the contamination, it was another sign that the way we currently manufacture heparin is simply unsafe," he said. "Unlike the current heparin that is harvested from possibly disease-carrying animals in often very poor conditions, our fully synthetic heparin will be created in a pharmaceutical manufacturing environment from fermentation to packaging. This will give drug manufacturers extreme control over the safety and purity of the product."
Linhardt, together with Jian Liu of the University of North Carolina in Chapel Hill, said they discovered the synthetic recipe for heparin in 2006. Since that time he has worked to grow a complex carbohydrate that is naturally created in the body in the lab.
He said that the carbohydrate backbone for the new heparin comes from the bacteria E. coli. The use of the common and easily grown bacteria makes this version of heparin much easier and faster to produce.
The dose that Linhardt and his team were able to produce with this method was “a million times higher than any other alternative created to date,” according to the researchers. He said he will now continue to work with his partners to take the milligram dose that they have developed and expand it to kilograms.
“Ultimately, drug companies are going to need to produce tons of this drug to keep up with global demand," Linhardt said. "Such levels of productions are further down the road. We think that in five years, it is very possible that this drug could reach human clinical trials.”