Many times innovation thrives in the wake of predicament. Earlier this year, the heparin-contamination issue sorely damaged consumers’ already delicate trust in the pharmaceutical industry but opened opportunities for several researchers to advance safer alternatives. Last week, at least two groups announced promising results toward this objective.
At the American Chemical Society national conference, scientists from Rensselaer Polytechnic Institute and the University of North Carolina reported they had created the first fully synthetic heparin and had created it at the milligram-dose level, which is the largest dose of heparin ever created in a lab. The project actually began two years ago, but the contamination incident helped foster awareness with the problems associated with traditional methods. As a synthetic, the drug has a higher level of purity than animal-sourced heparin and because the synthetic “backbone” comes from the familiar E. coli bacteria, manufacturers can produce it under controlled processing conditions. The team hopes to go to human clinical trials within 5 years.
Other researchers are looking at developing drugs that perform the same function as heparin but may be safer to produce. Researchers at Afid Therapeutics (Lansing, MI) said they had successfully demonstrated in vitro and in vivo efficacy of a “traceless” anticoagulant that reportedly mimics heparin. The drug produces only carbohydrates and amino acids upon degradation in the blood. Although no other details regarding the mechanisms of the anticoagulant are available, the important toxicity studies revealed that the viability of the mammalian cells did not change.
These are only two of several efforts undertaken to ensure safe production of heparin or heparin alternatives while fulfilling global demand. If you read or hear about others, be sure to let us know.