Comparative Evaluation of the Efficacy of Bioengineered Heparin versus Porcine USP Heparin
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Issue Date
2013
Authors
Vartigian, Nicole L. '13
Degree
MS in Biotechnology
Advisor
Mousa, Shaker
Committee Members
Lindhardt, Robert
Wheeler, Elyse
Wheeler, Elyse
Journal Title
Journal ISSN
Volume Title
Abstract
In this thesis the pharmacodynamics (anticoagulant efficacy) of porcine unfractionated heparin (USP heparin) versus bioengineered heparin are determined and compared. The development of a bioengineered heparin was triggered in response to heparin contamination that led to the death of more than 180 Americans in 2008 alone. Recent research suggests that it is possible to produce a bioengineered heparin from non-animal sources that will be equivalent to the current USP heparin. The bioequivalence of USP heparin versus bioengineered heparin was assessed using established in vitro and in vivo model systems for anticoagulant efficacy, anti-angiogenesis and potential anti-cancer effects. The versions of bioengineered heparin tested met the criteria set forth by the USP for heparin sulfate with regards to anti-factor Xa/IIa activity ratio and anti-factor IIa activity. In chorioallantoic membrane (CAM) models, there is a potential anti–angiogenic effect by both USP heparin as well as bioengineered heparin. Thrombelastography results followed a similar dose response when analyzed, indicating that the time for clot formation and strength of the clot have a comparable hemostatic profile. The bioengineered heparin has thus far been shown to be biologically equivalent to USP heparin with no statistically significant differences.
Citation
Vartigian, Nicole L. "Comparative Evaluation of the Efficacy of Bioengineered Heparin Versus Porcine Usp Heparin." Albany College of Pharmacy and Health Sciences, New York, Proquest/UMI, 2013.
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