Abstract
US manufacturers, concerned about bovine spongiform encephalopathy (BSE), ceased marketing bovine heparin in the 1990s. Recent short supplies of safe porcine heparin suggest that reintroducing bovine heparin might benefit public health. We purified heparin from crude bovine extract spiked with BSE agent, removing substantial infectivity and abnormal prion proteins (PrPTSE).
Highlights
US manufacturers, concerned about bovine spongiform encephalopathy (BSE), ceased marketing bovine heparin in the 1990s
In the 1990s, bovine-derived heparin was withdrawn from the US market because of concerns about possible contamination of bovine tissues with the agent of bovine spongiform encephalopathy (BSE), the causative agent of variant Creutzfeldt-Jakob disease in humans [1]
The US Food and Drug Administration has encouraged reintroduction of bovine-sourced heparin into the US market to improve the reliability of the heparin supply chain by diversifying sources [2,3]
Summary
US manufacturers, concerned about bovine spongiform encephalopathy (BSE), ceased marketing bovine heparin in the 1990s. We previously showed that a model 4-step bench-scale heparin manufacturing process cleared substantial amounts of spiked scrapie agent, a surrogate for BSE agent [5]. We spiked commercial crude bovine heparin with BSE agent itself and processed samples using the same manufacturing process we applied to scrapie agent.
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