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Please use this identifier to cite or link to this item: https://doi.org/10.21256/zhaw-19791
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dc.contributor.authorMöller, Johannes-
dc.contributor.authorHernández Rodríguez, Tanja-
dc.contributor.authorMüller, Jan-
dc.contributor.authorArndt, Lukas-
dc.contributor.authorKuchemüller, Kim B.-
dc.contributor.authorFrahm, Björn-
dc.contributor.authorEibl-Schindler, Regine-
dc.contributor.authorEibl, Dieter-
dc.contributor.authorPörtner, Ralf-
dc.date.accessioned2020-03-19T10:01:43Z-
dc.date.available2020-03-19T10:01:43Z-
dc.date.issued2019-12-23-
dc.identifier.issn0098-1354de_CH
dc.identifier.issn1873-4375de_CH
dc.identifier.urihttps://digitalcollection.zhaw.ch/handle/11475/19791-
dc.description.abstractReliable 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.de_CH
dc.language.isoende_CH
dc.publisherElsevierde_CH
dc.relation.ispartofComputers & Chemical Engineeringde_CH
dc.rightsLicence according to publishing contractde_CH
dc.subjectMonte Carlo methodde_CH
dc.subjectProcess modelingde_CH
dc.subjectParameter distributionde_CH
dc.subjectProcess validationde_CH
dc.subjectModel-assisted design of experimentsde_CH
dc.subjectQuality by designde_CH
dc.subject.ddc660: Technische Chemiede_CH
dc.titleModel uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processesde_CH
dc.typeBeitrag in wissenschaftlicher Zeitschriftde_CH
dcterms.typeTextde_CH
zhaw.departementLife Sciences und Facility Managementde_CH
zhaw.organisationalunitInstitut für Chemie und Biotechnologie (ICBT)de_CH
dc.identifier.doi10.1016/j.compchemeng.2019.106693de_CH
dc.identifier.doi10.21256/zhaw-19791-
zhaw.funding.euNode_CH
zhaw.originated.zhawYesde_CH
zhaw.pages.start106693de_CH
zhaw.publication.statussubmittedVersionde_CH
zhaw.volume134de_CH
zhaw.publication.reviewPeer review (Publikation)de_CH
zhaw.author.additionalNode_CH
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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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