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https://doi.org/10.15480/882.2600
Publisher DOI: | 10.1016/j.compchemeng.2019.106693 | Title: | Model uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processes | Language: | English | Authors: | Möller, Johannes Hernández Rodríguez, Tanja Müller, Jan Arndt, Lukas Kuchemüller, Kim Beatrice Frahm, Björn Eibl, Regine Eibl, Dieter Pörtner, Ralf ![]() |
Issue Date: | 4-Mar-2020 | Publisher: | Elsevier Science | Source: | Computers and Chemical Engineering (134): 106693 (2020-03-04) | Abstract (english): | Reliable scale-up of biopharmaceutical production processes is key in Quality by Design. In this study, a model-based workflow is described to evaluate the bioprocess dynamics during process transfer and scale-up computationally. First, a mathematical model describes the bioprocess dynamics of different state variables (e.g., cell density, titer). Second, the model parameter probability distributions are de- termined at different scales due to measurement uncertainty. Third, the quantified parameter distribu- tions are statistically compared to evaluate if the process dynamics have been changed. This workflow was tested for the scale-up of an antibody-producing CHO fed-batch process. Significant differences were identified between the process development (30 ml) and implementation (250 ml) scale, and the feeding strategy was validated using model-assisted Design of Experiments. Then, the validated process strategy was successfully scaled up to 2 l laboratory and 50 l pilot scale. In summary, the proposed workflow enables a knowledge-driven evaluation tool for bioprocess development. |
URI: | http://hdl.handle.net/11420/4596 | DOI: | 10.15480/882.2600 | ISSN: | 0098-1354 | Journal: | Computers & chemical engineering | Institute: | Bioprozess- und Biosystemtechnik V-1 | Document Type: | Article | Project: | IBÖM04:mDoE-Toolbox2-Neue mDoE Software-Toolbox zur modellgestützten Optimierung biotechnologischer Prozesse | More Funding information: | German Federal Ministry of Education and Research, projects: 031 B0305, 031 B0577A | License: | ![]() |
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Möller et al. Comp Chem Eng 2020.pdf | 3,61 MB | Adobe PDF | View/Open![]() |
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