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Accelerating Biomanufacturing by Modeling of Continuous Bioprocessing—Piloting Case Study of Monoclonal Antibody Manufacturing

Institute for Separation and Process Technology, Clausthal University of Technology, Leibnizstr. 15, 38678 Clausthal-Zellerfeld, Germany
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Processes 2019, 7(8), 495; https://doi.org/10.3390/pr7080495
Received: 24 May 2019 / Revised: 17 July 2019 / Accepted: 25 July 2019 / Published: 1 August 2019
(This article belongs to the Special Issue Processes Accelerating Biologics Manufacturing by Modelling)
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Abstract

An experimental feasibility study on continuous bioprocessing in pilot-scale of 1 L/day cell supernatant, that is, about 150 g/year product (monoclonal antibody) based on CHO (Chinese hamster ovary) cells for model validation is performed for about six weeks including preparation, start-up, batch, and continuous steady-state operation for at least two weeks stable operation as well as final analysis of purity and yield. A mean product concentration of around 0.4 g/L at cell densities of 25 × 106 cells/mL was achieved. After perfusion cultivation with alternating tangential flow filtration (ATF), an aqueous two-phase extraction (ATPE) followed by ultra-/diafiltration (UF/DF) towards a final integrated counter-current chromatography (iCCC) purification with an ion exchange (IEX) and a hydrophobic interaction (HIC) column prior to lyophilization were successfully operated. In accordance to prior studies, continuous operation is stable and feasible. Efforts of broadly-qualified operation personal as well as the need for an appropriate measurement and process control strategy is shown evidently. View Full-Text
Keywords: continuous bioprocessing (CBP); model validation; antibodies; quality-by-design (QbD); process analytical technology (PAT) continuous bioprocessing (CBP); model validation; antibodies; quality-by-design (QbD); process analytical technology (PAT)
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Kornecki, M.; Schmidt, A.; Lohmann, L.; Huter, M.; Mestmäcker, F.; Klepzig, L.; Mouellef, M.; Zobel-Roos, S.; Strube, J. Accelerating Biomanufacturing by Modeling of Continuous Bioprocessing—Piloting Case Study of Monoclonal Antibody Manufacturing. Processes 2019, 7, 495.

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