title: Process simulation for recombinant protein production: cost estimation and sensitivity analysis for heparinase I expressed in Escherichia coli.
abstract: 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.
authors.affiliation: Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139, USA.
authors.forename: S
authors.initials: S
authors.lastname: Ernst
authors.forename: O A
authors.initials: OA
authors.lastname: Garro
authors.forename: S
authors.initials: S
authors.lastname: Winkler
authors.forename: G
authors.initials: G
authors.lastname: Venkataraman
authors.forename: R
authors.initials: R
authors.lastname: Langer
authors.forename: C L
authors.initials: CL
authors.lastname: Cooney
authors.forename: R
authors.initials: R
authors.lastname: Sasisekharan