Abstract Number: PB0126
Meeting: ISTH 2021 Congress
Background: The current shortage of porcine heparin has warranted the development of alternate source heparins from bovine and ovine mucosa. On a mass basis, porcine and ovine heparins exhibit similar potencies (200 units/mg) which are higher than their bovine counterparts (130-150 units/mg).
Aims: We compared porcine, ovine, and bovine heparins at USP potency-equated levels in standardized assays used for measuring and monitoring heparins.
Methods: Porcine (200 units/mg), ovine (200 units/mg), and bovine (140 units/mg) heparins were obtained from Medefil Inc. (Glendale Heights, IL), Ronnsi Pharmaceutical (Jiangsu, China), and Kin Master Pharmaceuticals (Posso Fundo, Brazil), respectively. The anticoagulant effect of all heparins was evaluated using whole blood clotting assays such as ACT and thromboelastographic methods and clot based assays such as aPTT, TT, and prothrombinase induced clotting time (PiCT). Thrombin generation inhibition assay was carried out using a kinetic assay. Protamine and heparinase neutralization of these agents were also investigated in both the mass and potency adjusted concentrations. All results were tabulated and compared, and applicable statistical methods were applied.
Results: The USP potency adjusted heparin exhibited comparable anticoagulant effects in both the ACT and TEG assays. At equigravimetric levels porcine and ovine heparins produced comparable anticoagulant effects and bovine heparin produced weaker anticoagulant effects. All heparins produced similar anticoagulant effects at potency adjusted dosages. In the anti-Xa, anti-IIa, and thrombin generation assays, all agents were comparable. Potency adjusted bovine heparin required higher amount of protamine for the complete neutralization in comparison to ovine and porcine heparin.
Conclusions: These results show that, at potency adjusted concentrations, porcine, ovine, and bovine heparins exhibit comparable biochemical and anticoagulant responses in the plasma-based systems. Therefore, it appears that potency-equated porcine, ovine, and bovine heparins exhibit comparable biochemical and anticoagulant activities.
To cite this abstract in AMA style:Baig N, Jaradeh M, Kouta A, Jeske W, Hoppensteadt D, Walenga J, Iqbal O, Siddiqui F, Bakhos M, Fareed J. Validation of the Bioequivalence of USP Potency Adjusted Porcine, Ovine and Bovine Heparins [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/validation-of-the-bioequivalence-of-usp-potency-adjusted-porcine-ovine-and-bovine-heparins/. Accessed December 5, 2021.
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