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Antibodies 2018, 7(1), 13; https://doi.org/10.3390/antib7010013

Evaluation of Continuous Membrane Chromatography Concepts with an Enhanced Process Simulation Approach

Institute for Separation and Process Technology, Clausthal University of Technology, Leibnizstraße 15, D-38678 Clausthal-Zellerfeld, Germany
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Received: 3 January 2018 / Revised: 20 February 2018 / Accepted: 27 February 2018 / Published: 2 March 2018
(This article belongs to the Special Issue Analytical Methodologies for Antibodies)
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Abstract

Modern biopharmaceutical products strive for small-scale, low-cost production. Continuous chromatography has shown to be a promising technology because it assures high-capacity utilization, purity and yield increases, and lower facility footprint. Membrane chromatography is a fully disposable low-cost alternative to bead-based chromatography with minor drawbacks in terms of capacity. Hence, continuous membrane chromatography should have a high potential. The evaluation of continuous processes goes often along with process modeling. Only few experiments with small feed demand need to be conducted to estimate the model parameters. Afterwards, a variety of different process setups and working points can be analyzed in a very short time, making the approach very efficient. Since the available modeling approaches for membrane chromatography modules did not fit the used design, a new modeling approach is shown. This combines the general rate model with an advanced fluid dynamic distribution. Model parameter determination and model validation were done with industrial cell cultures containing Immunoglobulin G (IgG). The validated model was used to evaluate the feasibility of the integrated Counter Current Chromatography (iCCC) concept and the sequential chromatography concept for membrane adsorber modules, starting with a laboratory-type module used for sample preparation. A case study representing a fed-batch reactor with a capacity from 20 to 2000 L was performed. Compared to batch runs, a 71% higher capacity, 48.5% higher productivity, and 38% lower eluent consumption could be achieved. View Full-Text
Keywords: continuous chromatography; membrane chromatography; process modeling; continuous bio-manufacturing continuous chromatography; membrane chromatography; process modeling; continuous bio-manufacturing
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Zobel-Roos, S.; Stein, D.; Strube, J. Evaluation of Continuous Membrane Chromatography Concepts with an Enhanced Process Simulation Approach. Antibodies 2018, 7, 13.

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