Drug intelligence / Profile preview

biosynthetic heparin

Development stage
Preclinical
Lead developer
Rensselaer Polytechnic Institute
Administration
Intravenous, Subcutaneous
01

Overview

**Biosynthetic heparin** is an animal-free anticoagulant polysaccharide produced via chemoenzymatic synthesis from *E. coli* K5-derived heparosan, addressing supply chain vulnerabilities and contamination risks of porcine-derived heparin. It undergoes sequential enzymatic modifications—including C5-epimerization, 2-O-, 6-O-, and 3-O-sulfation using engineered sulfotransferases and cofactor recycling—to mimic the structure and activity of unfractionated heparin (UFH), with anti-FXa activity of ~241-246 IU/mg, anti-FIIa ~246 IU/mg, molecular weight ~17,600 Da, and potential conversion to low molecular weight heparin (LMWH) akin to enoxaparin. Developed through academic-industrial efforts, it offers a scalable, sustainable alternative for preventing/treating thrombosis, surgical anticoagulation, and dialysis, meeting USP specifications for potency and composition.[1][2][3]

Other names
bioengineered heparinBEHBSH
02

Targets

ATIII (Antithrombin III)F2 (Thrombin)F10 (Factor Xa)

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