Process Simulation for Recombinant Protein-Production - Cost Estimation and Sensitivity Analysis for Heparinase-I Expressed in Escherichia-Coli

ERNST, S; GARRO, OA; WINKLER, S; VENKATARAMAN, G; LANGER, R; COONEY, CL; SASISEKHARAN, R; OSCAR ALFREDO GARRO

BIOTECHNOLOGY AND BIOENGINEERING

Año: 1997 vol. 53 p. 575 - 582

Abstract: Heparinase I from Flavobacterium heparinumhas several potential clinical applications; the resultinghigh demands on protein purity and quantity can be metby recombinant expression in Escherichia coli. Based onlaboratory scale experiments with insoluble heparinase Iexpression followed by renaturation, a process for productionof 3 kg/year of heparinase I was designed. Wepresent a comparative analysis of the production costs ofsoluble and insoluble heparinase I expression, as well asa generalized approach to sensitivity analysis, based onperturbation around a base case design scenario. Thismay assist focusing further development on processsteps for which improvements both are feasible and resultin significant cost saving. © 1997 John Wiley & Sons,Inc. Biotechnol Bioeng 53: 575–582, 1997.Keywords: recombinant protein production; Escherichiacoli; heparinase; bioprocess simulation