Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

Nov 02, 2015

By David Keire, Barbara Mulloy, Christina Chase, Ali Al-Hakim, Damian Cairatti,Elaine Gray, John Hogwood, Tina Morris, Paulo Mourão, Monica Da Luz Carvalho Soares, Anita Szajek

Pharmaceutical Technology

Volume 39, Issue 11

Courtesy of the US Pharmacopeial Convention.Heparin regulates hemostasis at various points of the coagulation cascade mainly through its interaction with antithrombin and heparin cofactor II. Because of these properties, heparin is a life-saving anticoagulant drug used in renal dialysis, cardiac surgery, and treatment for deep vein thrombosis. The drug also binds to platelets, inhibiting platelet function and contributing to the hemorrhagic effects of heparin. Bovine heparin, first approved in 1939, was widely used in the United States for more than 50 years (see Figure 1). Like all drugs, heparin can cause adverse effects, but overall, bovine heparin products were found to be safe and effective during that period.

Figure 1: Historical development timeline of therapeutic heparin in United States.[Courtesy of Authors]Read the full text here