Bovine Heparin Meets Acceptable Impurity Levels

A recent study has demonstrated that bovine heparin can be produced to meet acceptable impurity levels, as defined by the US Pharmacopeia (USP), supporting the use of bovine-derived heparin as an alternative to porcine heparin.

The supply chain for porcine heparin, which is derived from porcine intestines, is subject to disruptions due to agricultural and economic conditions. In 2007–2008, the intentional contamination of batches of porcine heparin-sourced from China-with oversulfated chondroitin sulfate (OSCS) resulted in side effects for patients and nearly 100 deaths. 

In 2018, FDA encouraged the reintroduction of bovine-sourced heparin, noting the need to take proactive approaches to address possible shortages or contamination of the porcine heparin supply.

The USP paper, “Quantitative Analysis of Impurities in Unfractionated Heparin of Bovine Origin,” by Wes Workman and Kevin Carrick, published in the January 2020 issue of Frontiers in Medicine, reviews the results of an evaluation of bovine heparin with the current USP heparin sodium monograph methods.

USP worked with independent laboratories to analyze test and control samples for impurities and evaluate whether the tests and limits for impurities, including OSCS, in the USP heparin standard could be applied to bovine heparin. Test results for bovine heparin were comparable to porcine heparin with respect to impurity levels, with both falling within acceptable ranges, the study reported.

“Heparin shortages would have serious-in some cases life-threatening-repercussions for patients,” said Jaap Venema, executive vice president, chief science officer at USP in a USP press statement. “USP will continue to research and develop science-based solutions to help address public health challenges and medicine quality.”

Source: USP