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https://doi.org/10.21256/zhaw-19791| Publikationstyp: | Beitrag in wissenschaftlicher Zeitschrift |
| Art der Begutachtung: | Peer review (Publikation) |
| Titel: | Model uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processes |
| Autor/-in: | Möller, Johannes Hernández Rodríguez, Tanja Müller, Jan Arndt, Lukas Kuchemüller, Kim B. Frahm, Björn Eibl-Schindler, Regine Eibl, Dieter Pörtner, Ralf |
| et. al: | No |
| DOI: | 10.1016/j.compchemeng.2019.106693 10.21256/zhaw-19791 |
| Erschienen in: | Computers & Chemical Engineering |
| Band(Heft): | 134 |
| Seite(n): | 106693 |
| Erscheinungsdatum: | 23-Dez-2019 |
| Verlag / Hrsg. Institution: | Elsevier |
| ISSN: | 0098-1354 1873-4375 |
| Sprache: | Englisch |
| Schlagwörter: | Monte Carlo method; Process modeling; Parameter distribution; Process validation; Model-assisted design of experiments; Quality by design |
| Fachgebiet (DDC): | 660: Technische Chemie |
| Zusammenfassung: | 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 determined at different scales due to measurement uncertainty. Third, the quantified parameter distributions 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: | https://digitalcollection.zhaw.ch/handle/11475/19791 |
| Volltext Version: | Eingereichte Version |
| Lizenz (gemäss Verlagsvertrag): | Lizenz gemäss Verlagsvertrag |
| Departement: | Life Sciences und Facility Management |
| Organisationseinheit: | Institut für Chemie und Biotechnologie (ICBT) |
| Enthalten in den Sammlungen: | Publikationen Life Sciences und Facility Management |
Dateien zu dieser Ressource:
| Datei | Beschreibung | Größe | Format | |
|---|---|---|---|---|
| 2019_Moeller-etal_Model-certainty-based-evaluation-of-process-strategies.pdf | 5.37 MB | Adobe PDF |  Öffnen/Anzeigen |
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Möller, J., Hernández Rodríguez, T., Müller, J., Arndt, L., Kuchemüller, K. B., Frahm, B., Eibl-Schindler, R., Eibl, D., & Pörtner, R. (2019). Model uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processes. Computers & Chemical Engineering, 134, 106693. https://doi.org/10.1016/j.compchemeng.2019.106693
Möller, J. et al. (2019) ‘Model uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processes’, Computers & Chemical Engineering, 134, p. 106693. Available at: https://doi.org/10.1016/j.compchemeng.2019.106693.
J. Möller et al., “Model uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processes,” Computers & Chemical Engineering, vol. 134, p. 106693, Dec. 2019, doi: 10.1016/j.compchemeng.2019.106693.
MÖLLER, Johannes, Tanja HERNÁNDEZ RODRÍGUEZ, Jan MÜLLER, Lukas ARNDT, Kim B. KUCHEMÜLLER, Björn FRAHM, Regine EIBL-SCHINDLER, Dieter EIBL und Ralf PÖRTNER, 2019. Model uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processes. Computers & Chemical Engineering. 23 Dezember 2019. Bd. 134, S. 106693. DOI 10.1016/j.compchemeng.2019.106693
Möller, Johannes, Tanja Hernández Rodríguez, Jan Müller, Lukas Arndt, Kim B. Kuchemüller, Björn Frahm, Regine Eibl-Schindler, Dieter Eibl, and Ralf Pörtner. 2019. “Model Uncertainty-Based Evaluation of Process Strategies during Scale-up of Biopharmaceutical Processes.” Computers & Chemical Engineering 134 (December): 106693. https://doi.org/10.1016/j.compchemeng.2019.106693.
Möller, Johannes, et al. “Model Uncertainty-Based Evaluation of Process Strategies during Scale-up of Biopharmaceutical Processes.” Computers & Chemical Engineering, vol. 134, Dec. 2019, p. 106693, https://doi.org/10.1016/j.compchemeng.2019.106693.
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