Heparin Contamination and Issues Related to Raw Materials and Controls

Abstract

Heparin is a century-old polypharmacological drug critical for the practice of modern medicine. In recent years, there have been a number of issues arising in the preparation of heparin from food animal tissues. The most severe problem was the adulteration of porcine intestinal heparin with a toxic semisynthetic look-alike polysaccharide, oversulfated chondroitin sulfate, which resulted in a number of patient deaths. Since this crisis, regulatory and analytical control of heparin has been markedly improved; new challenges in securing the heparin supply chain have prompted the reintroduction of heparins from new animal sources. In future, the introduction of bioengineered heparins might offer better approaches for securing this critical drug.