While making a presentation on their work at the national conference of the American Chemical Society on Sunday, the researchers insisted that their creation was the largest dose of heparin ever created in the lab.
The main source of heparin is the intestines of foreign livestock, and the risk of contamination from such sources is high.
In the spring of 2008, more than 80 people around the world died, and hundreds became ill after being administered what was believed to be contaminated batches of heparin.
Robert Linhardt, a member of the international team that was formed to search for a safer alternative to the common drug, has revealed that they 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. 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," he said.
Working in collaboration with Jian Liu of the University of North Carolina, Linhardt discovered the synthetic "recipe" for heparin in 2006.
He had since been working to piece together the various molecules and grow in the lab a complex carbohydrate, which is naturally created in the body.
According to Linhardt, the carbohydrate backbone for the new heparin comes from the bacteria E. coli, and the use of the common and easily grown bacteria makes this version of heparin much easier and faster to produce.
He and his colleagues used a process called chemoenzymatic synthesis that used specialized synthetic chemicals and natural enzymes expressed in E. coli to replicate the normal biosynthesis of natural heparin within the cell.
The dose that the researchers were able to produce with the new approach was a million times higher than any other alternative created to date.
Linhardt says that he will 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. 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," he said.