Please use this identifier to cite or link to this item: https://doi.org/10.15480/882.2600
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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 Beatrice-
dc.contributor.authorFrahm, Björn-
dc.contributor.authorEibl, Regine-
dc.contributor.authorEibl, Dieter-
dc.contributor.authorPörtner, Ralf-
dc.date.accessioned2020-01-28T12:23:12Z-
dc.date.available2020-01-28T12:23:12Z-
dc.date.issued2020-03-04-
dc.identifier.citationComputers and Chemical Engineering (134): 106693 (2020-03-04)de_DE
dc.identifier.issn0098-1354de_DE
dc.identifier.urihttp://hdl.handle.net/11420/4596-
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 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. ©2020 Elsevier Ltd. All rights reserved.en
dc.language.isoende_DE
dc.publisherElsevier Sciencede_DE
dc.relation.ispartofComputers & chemical engineeringde_DE
dc.rightsCC BY 4.0de_DE
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subject.ddc570: Biowissenschaften, Biologiede_DE
dc.titleModel uncertainty-based evaluation of process strategies during scale-up of biopharmaceutical processesde_DE
dc.typeArticlede_DE
dc.identifier.doi10.15480/882.2600-
dc.type.diniarticle-
dcterms.DCMITypeText-
tuhh.identifier.urnurn:nbn:de:gbv:830-882.067826-
tuhh.oai.showtruede_DE
tuhh.abstract.englishReliable 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. ©2020 Elsevier Ltd. All rights reserved.de_DE
tuhh.publisher.doi10.1016/j.compchemeng.2019.106693-
tuhh.publication.instituteBioprozess- und Biosystemtechnik V-1de_DE
tuhh.identifier.doi10.15480/882.2600-
tuhh.type.opus(wissenschaftlicher) Artikel-
dc.type.driverarticle-
dc.type.casraiJournal Article-
tuhh.container.volume134de_DE
dc.relation.projectIBÖM04:mDoE-Toolbox2-Neue mDoE Software-Toolbox zur modellgestützten Optimierung biotechnologischer Prozesse-
dc.rights.nationallicensefalsede_DE
tuhh.container.articlenumber106693de_DE
local.status.inpressfalsede_DE
local.funding.infoGerman Federal Ministry of Education and Research, projects: 031 B0305, 031 B0577Ade_DE
item.creatorOrcidMöller, Johannes-
item.creatorOrcidHernández Rodríguez, Tanja-
item.creatorOrcidMüller, Jan-
item.creatorOrcidArndt, Lukas-
item.creatorOrcidKuchemüller, Kim Beatrice-
item.creatorOrcidFrahm, Björn-
item.creatorOrcidEibl, Regine-
item.creatorOrcidEibl, Dieter-
item.creatorOrcidPörtner, Ralf-
item.openairetypeArticle-
item.openairecristypehttp://purl.org/coar/resource_type/c_6501-
item.fulltextWith Fulltext-
item.mappedtypeArticle-
item.creatorGNDMöller, Johannes-
item.creatorGNDHernández Rodríguez, Tanja-
item.creatorGNDMüller, Jan-
item.creatorGNDArndt, Lukas-
item.creatorGNDKuchemüller, Kim Beatrice-
item.creatorGNDFrahm, Björn-
item.creatorGNDEibl, Regine-
item.creatorGNDEibl, Dieter-
item.creatorGNDPörtner, Ralf-
item.cerifentitytypePublications-
item.grantfulltextopen-
item.languageiso639-1en-
crisitem.project.funderBundesministerium für Bildung und Forschung (BMBF)-
crisitem.project.funderid501100002347-
crisitem.project.funderrorid04pz7b180-
crisitem.project.grantno031B0577A-
crisitem.author.deptBioprozess- und Biosystemtechnik V-1-
crisitem.author.deptBioprozess- und Biosystemtechnik V-1-
crisitem.author.deptBioprozess- und Biosystemtechnik V-1-
crisitem.author.deptBioprozess- und Biosystemtechnik V-1-
crisitem.author.deptBioprozess- und Biosystemtechnik V-1-
crisitem.author.orcid0000-0001-9546-055X-
crisitem.author.orcid0000-0002-7667-8390-
crisitem.author.orcid0000-0003-4046-7804-
crisitem.author.orcid0000-0003-1163-9718-
crisitem.author.parentorgStudiendekanat Verfahrenstechnik-
crisitem.author.parentorgStudiendekanat Verfahrenstechnik-
crisitem.author.parentorgStudiendekanat Verfahrenstechnik-
crisitem.author.parentorgStudiendekanat Verfahrenstechnik-
crisitem.author.parentorgStudiendekanat Verfahrenstechnik-
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