Why it matters: Heparin contaminated with oversulfated chondroitin sulfate killed dozens of patients in the United States and Germany in 2008, and health officials want to prevent future similar incidents. Heparin is commonly used as a blood thinner during heart surgery and dialysis.
“There are constant challenges in heparin manufacturing, due to cost and the complexity of the product,” says Ram Sasisekharan, the Edward Hood Taplin Professor and director of the Harvard-MIT Division of Health Sciences and Technology (HST), who led the research team. “It’s very important to ensure that there is a safe supply to hospitals in this country and the world over.”
Methods: Manufacturing heparin is a complex process that produces many byproducts, some of which are similar to heparin. Given that similarity to heparin, these compounds could be used to generate oversulfated materials that mimic heparin but have potentially adverse side effects. The researchers found that the current screening methods – nuclear magnetic resonance (NMR) and capillary electrophoresis (CE) – can distinguish these compounds (and their oversulfated derivatives) from heparin. Though the researchers found no evidence that any of these other oversulfated materials were present in last year’s contaminated heparin batches, they found that the proposed testing scheme would detect these contaminants if they were present.
Next steps: The researchers are creating a database of the chemical signatures of potential contaminants, so manufacturers can easily identify them. The team also outlined follow-up tests to be done if anything suspicious is found in the initial screening.
Source: “Orthogonal Analytical Approaches to Detect Potential Contaminants in Heparin,” Marco Guerrini, Ram Sasisekharan, et al
Proceedings of the National Academy of Sciences, week of Sept. 21, 2009
Funding: National Institutes of Health
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