A Comparison of Ovine and Porcine Heparins and Enoxaparins: A Case for an Alternative Source of Heparin Products
Authors: Bouchard Olivia , Abro Schuharazad , Kahn Daniel , Iqbal Omer , Hoppensteadt Debra , Yao Yiming , Fareed Jawed 
Published: November 2023

Introduction

The need of alternative sources of heparins, and low molecular weight heparins, has become necessary worldwide as branded porcine products have become less accessible. Heparins and LMWHs derived from bovine and ovine sources are possible alternatives. This study evaluated the clotting activities of six ovine products as compared to their branded porcine alternatives. The anti‐coagulant and anti‐protease activities of ovine derived heparins and LWMHs in comparison to their porcine counterparts were investigated in whole blood and retrieved plasma.

Methods

The six ovine products were obtained from Ronssi Phamaceuticals, China. The branded porcine products were obtained from commercial sources. Human whole blood was prepared by drawing healthy donors. Platelet rich plasma was prepared by differential centrifugation of citrated whole blood from the donors. The individual drugs were supplemented into freshly drawn whole blood at final concentrations of 0 to 10 ug/mL. Four tests were performed for the comparison of the products: APTT, Thrombin time (TT), Anti‐Xa and Anti‐IIa on whole blood and retrieved plasma.

Results

In the whole blood studies for APTT, the anti‐coagulant effects were similar for the all of the heparin agents, with slight variations at a concentration of 5 ug/mL. The enoxaparins exhibited similar results in APTT as well, with slightly stronger activity with the branded product above 5 ug/mL. In the TT test with whole blood, the results were all similar for the drugs tested, with slight variation between all drugs at a concentration of 5 ug/mL.

The retrieved plasma studies showed similar results between the six ovine products in the Anti‐Xa assay, which compared to the branded products. In the Anti‐IIa assay for the plasma studies, all six agents behaved similarly, and little to no differences were noted between these drugs. The APTT assay results showed comparable anti‐coagulant activity for all drugs. The TT assay showed comparable results for the all drugs, with slight variation at concentrations under 7.5 ug/mL for the enoxaparins.

Discussion

A comparison between the whole blood and retrieved plasma revealed stronger anti‐coagulant activity in the plasma assays as compared to the whole blood assays. In the comparison between the whole blood and plasma, the ovine products exhibited comparable results to the porcine products. Overall, the ovine drugs have similar profiles to one another and exhibit similar anti‐coagulant and anti‐protease activities in the assays conducted in this study. This study demonstrated that these ovine products are comparable to standard porcine products commonly used today.

Clinical Implications

The results of this study validated the biosimilarity of ovine heparins and LMWHs to their porcine counterparts. The option of having a choice between ovine and porcine heparins will make these drugs more acceptable and accessible to a wider patient population.

Support or Funding Information

Internal Funding.