Bovine and Porcine Mucosal Heparins Exhibit Similar Biologic Profiles

Abstract

IntroductionIn consideration of the limited supply of porcine heparin (PH), which may result in a global shortage, the current discussions on the reintroduction of bovine heparin (BH) are timely and justified. This study compared 5 different batches each of BHs and PHs both of mucosal origin.Materials and MethodsCommercially available PHs and BH were obtained from various US and Brazilian vendors. USP reference standard heparin (Lot F01187) was used to compare the potency of these two groups of heparin utilizing ACT, aPTT, Heptest, Calcium Thrombin Time, anti‐Xa and anti‐IIa activities, as well as protamine and PF4 neutralization. The interaction with HIT antibodies was studied using a pooled HIT sera preparation. The molecular weight profile was determined by HPLC.ResultsOn a gravimetric basis, the anticoagulant activity of PH was 10‐30% higher in comparison to BH. PH exhibited higher anti‐Xa and anti‐IIa activities. The USP cross referenced potency in the anti‐Xa assay was 160+20 U/mg for PH vs 132+16 U/mg for BH. Protamine and PF4 titration profiles were comparable. In the HIT assay, there was no difference in between the two groups. .The molecular weight of BH was 17.1 ± 0.8 kDa, whereas that of PH was 16.6 ± 0.5 k Da (p>0.05).ConclusionWhile PH exhibits relatively stronger anticoagulant and anti‐protease activities, in other assays both BH and PH exhibit comparable compositional and functional profiles. Thus, BH may be considered as biosimilar to PH and can be accordingly defined and developed for clinical use.