Abstract Number: PB0201
Meeting: ISTH 2020 Congress
Background: Heparins are extracted from the mast cell rich mammalian tissues such as lung and intestine. Heparin is primarily derived from porcine mucosa (PMH), bovine mucosal heparins (BMH) are currently being considered by the FDA for re-introduction in medical and surgical procedures as an alternative to porcine mucosal heparins (PMH). We hypothesized that at USP potency equated levels, BMH and PMH should be comparable, however at gravimetric concentrations, mass adjusted PMH should exhibit stronger anticoagulant effects in comparison to BMH.
Aims: The purpose of this study is to compare the clotting profiles and biological properties of mass and USP potency equated BMH and PMH.
Methods: Powdered form of pharmaceutical grade BMH (140 U/mg), PMH (190 U/mg) and protamine sulfate were obtained from commercial vendors. Whole blood thromboelastographic studies were carried out in TEG 5000 Hemostasis system. Clotting (TT and aPTT) and anti-protease (anti-Xa and anti-IIa) assay were measured by using ACL instrument. Relative neutralization by protamine sulfate was carried out at a fixed concentration of 10 ug/ml.
Results: In whole blood TEG, clotting profile and anti-protease, USP potency equated BMH and PMH showed comparable effects. Protamine sulfate at 10 ug/ml completely neutralized BMH and PMH in a comparable fashion except anti-IIa assay. In mass ratio, PMH showed strong effects in all assays compare to BMH. BMH and PMH were completely neutralized by protamine sulfate in clotting assay, however in anti-protease assay BMH was completely neutralized while PMH was only partially neutralized at higher concentrations.
Conclusions: These studies suggest that mass porcine heparin exhibits stronger effects compared to bovine heparin. However, at USP potency adjusted levels, bovine and porcine heparins exhibit comparable effects sand can be considered biosimilar. These studies conclude that bovine heparin can be an alternative source of heparin to the prominent porcine heparin.
To cite this abstract in AMA style:Krishnappan S, Siddiqui F, Farooqui A, Iqbal O, Kouta A, Hoppensteadt D, Jeske W, Walenga J, Fareed J. A Comparison of Mass and Potency Equated Bovine and Porcine Heparins [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/a-comparison-of-mass-and-potency-equated-bovine-and-porcine-heparins/. Accessed March 3, 2021.
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