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Process simulation for recombinant protein production: Cost estimation and sensitivity analysis for heparinase I expressed in Escherichia coli

✍ Scribed by Steffen Ernst; Oscar A. Garro; Stefan Winkler; Ganesh Venkataraman; Robert Langer; Charles L. Cooney; Ram Sasisekharan


Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
199 KB
Volume
53
Category
Article
ISSN
0006-3592

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✦ Synopsis


Heparinase I from Flavobacterium heparinum has several potential clinical applications; the resulting high demands on protein purity and quantity can be met by recombinant expression in Escherichia coli. Based on laboratory scale experiments with insoluble heparinase I expression followed by renaturation, a process for production of 3 kg/year of heparinase I was designed. We present a comparative analysis of the production costs of soluble and insoluble heparinase I expression, as well as a generalized approach to sensitivity analysis, based on perturbation around a base case design scenario. This may assist focusing further development on process steps for which improvements both are feasible and result in significant cost saving.