Researchers have developed a new process for manufacturing ultra-low molecular weight heparin, and they believe it’s superior to current methods.
In addition to reducing the potential for contamination, this process produced 2 structurally homogeneous ultra-low molecular weight heparins that were identical in performance and safety to fondaparinux. But these heparins were purer, faster, and less expensive to produce.
Robert Linhardt, PhD, of Rensselaer Polytechnic Institute in New York, and his colleagues reported their discovery in the October 28 edition of Science.
“With this discovery, we have successfully demonstrated that replacing the current model of drug production with a chemoenzymatic approach can greatly reduce the cost of drug development and manufacturing, while also increasing drug performance and safety . . . ,” Dr Linhardt said.
These heparins—like fondaparinux—were chemically synthesized from non-animal materials. So the risk of contamination is reduced, when compared to the risk with traditional heparin production.
In addition, the new production process is superior to that used with fondaparinux, the researchers said. The new process requires 10 to 12 steps, whereas fondaparinux production requires roughly 50.
The investigators were also able to increase the heparin yield 500-fold with the new process. They said it could decrease the cost of manufacture by a similar amount.
And the ultra-low molecular weight heparins proved to be as effective as fondaparinux in rabbit models.
“[W]e were able to quickly build multiple doses in a simple laboratory setting and feel that this is something than can be quickly and easy commercialized to reduce the cost of this drug and help to shift how pharmaceutical companies approach the synthesis of carbohydrate-containing drugs,” Dr Linhardt said.
These findings are part of a larger body of work in the Linhardt lab to completely replace all types of heparin-based or other glycoprotein-based drugs with safer, low-cost, synthetic versions that do not rely on foreign, potentially contaminated animal sources.
