A combination of chemicals and enzymes may be at the center of big efficiency improvements in drug-making. Researchers working on a chemoenzymatic approach to the manufacture of heparin say they've found their way to a 5-fold reduction in process steps, a 500-fold yield increase, as well as sharp reductions in cost.
Professor Robert Linhardt of Rensselaer Polytechnic Institute and research partner Jian Liu of the University of North Carolina at Chapel Hill have been working under a National Institutes of Health grant to replace the anticoagulant with a safer, inexpensive substitute that requires no animal sources, according to domain-b.
The new process reduces to 10 or 12 the number of steps involved in traditional 50-step heparin production, which is based on materials from pig and cattle organs. Instead, the new process uses chemical sources to build heparin core material "sugar by sugar." It also uses enzymes to produces sulfate groups that "control [the material's] structure and function in the body," the report says.
''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," said Linhardt, in the report. The process also aids drug performance and safety and reduces the likelihood of contamination, he added.
In addition, the process increases yield "500-fold" versus the current process used to make the material, called fondaparinux. It could decrease the cost of manufacture "by a similar amount," according to Linhardt. "It is our hope that his is the first step in the adoption of this method for the manufacture of many other drugs."
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