Hybrid modeling as a QbD/PAT tool in process development

Detalhes bibliográficos
Autor(a) principal: von Stosch, Moritz
Data de Publicação: 2016
Outros Autores: Hamelink, Jan Martijn, Oliveira, Rui
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/153855
Resumo: The authors thank Chi Chung (Tim) Choi and Paul Rice for their collaboration in batch production and performing off-line sample analysis and Carl Hémond for providing the RP-HPLC assay and results. The authors thank Paul Rice also for critical reading of the manuscript. © Copyright 2017 Elsevier B.V., All rights reserved.
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spelling Hybrid modeling as a QbD/PAT tool in process developmentan industrial E. coli case studyDynamic modelingE. coliHigh cell density fermentationHybrid modelingUpstream bioprocess development/optimizationBiotechnologyBioengineeringThe authors thank Chi Chung (Tim) Choi and Paul Rice for their collaboration in batch production and performing off-line sample analysis and Carl Hémond for providing the RP-HPLC assay and results. The authors thank Paul Rice also for critical reading of the manuscript. © Copyright 2017 Elsevier B.V., All rights reserved.Process understanding is emphasized in the process analytical technology initiative and the quality by design paradigm to be essential for manufacturing of biopharmaceutical products with consistent high quality. A typical approach to developing a process understanding is applying a combination of design of experiments with statistical data analysis. Hybrid semi-parametric modeling is investigated as an alternative method to pure statistical data analysis. The hybrid model framework provides flexibility to select model complexity based on available data and knowledge. Here, a parametric dynamic bioreactor model is integrated with a nonparametric artificial neural network that describes biomass and product formation rates as function of varied fed-batch fermentation conditions for high cell density heterologous protein production with E. coli. Our model can accurately describe biomass growth and product formation across variations in induction temperature, pH and feed rates. The model indicates that while product expression rate is a function of early induction phase conditions, it is negatively impacted as productivity increases. This could correspond with physiological changes due to cytoplasmic product accumulation. Due to the dynamic nature of the model, rational process timing decisions can be made and the impact of temporal variations in process parameters on product formation and process performance can be assessed, which is central for process understanding.DQ - Departamento de QuímicaLAQV@REQUIMTERUNvon Stosch, MoritzHamelink, Jan MartijnOliveira, Rui2023-06-12T22:17:17Z2016-05-012016-05-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article12application/pdfhttp://hdl.handle.net/10362/153855engvon Stosch, M., Hamelink, J. M., & Oliveira, R. (2016). Hybrid modeling as a QbD/PAT tool in process development: an industrial E. coli case study. Bioprocess and Biosystems Engineering, 39(5), 773-784. https://doi.org/10.1007/s00449-016-1557-11615-7591PURE: 14322505https://doi.org/10.1007/s00449-016-1557-1info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:36:20Zoai:run.unl.pt:10362/153855Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:55:24.519252Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Hybrid modeling as a QbD/PAT tool in process development
an industrial E. coli case study
title Hybrid modeling as a QbD/PAT tool in process development
spellingShingle Hybrid modeling as a QbD/PAT tool in process development
von Stosch, Moritz
Dynamic modeling
E. coli
High cell density fermentation
Hybrid modeling
Upstream bioprocess development/optimization
Biotechnology
Bioengineering
title_short Hybrid modeling as a QbD/PAT tool in process development
title_full Hybrid modeling as a QbD/PAT tool in process development
title_fullStr Hybrid modeling as a QbD/PAT tool in process development
title_full_unstemmed Hybrid modeling as a QbD/PAT tool in process development
title_sort Hybrid modeling as a QbD/PAT tool in process development
author von Stosch, Moritz
author_facet von Stosch, Moritz
Hamelink, Jan Martijn
Oliveira, Rui
author_role author
author2 Hamelink, Jan Martijn
Oliveira, Rui
author2_role author
author
dc.contributor.none.fl_str_mv DQ - Departamento de Química
LAQV@REQUIMTE
RUN
dc.contributor.author.fl_str_mv von Stosch, Moritz
Hamelink, Jan Martijn
Oliveira, Rui
dc.subject.por.fl_str_mv Dynamic modeling
E. coli
High cell density fermentation
Hybrid modeling
Upstream bioprocess development/optimization
Biotechnology
Bioengineering
topic Dynamic modeling
E. coli
High cell density fermentation
Hybrid modeling
Upstream bioprocess development/optimization
Biotechnology
Bioengineering
description The authors thank Chi Chung (Tim) Choi and Paul Rice for their collaboration in batch production and performing off-line sample analysis and Carl Hémond for providing the RP-HPLC assay and results. The authors thank Paul Rice also for critical reading of the manuscript. © Copyright 2017 Elsevier B.V., All rights reserved.
publishDate 2016
dc.date.none.fl_str_mv 2016-05-01
2016-05-01T00:00:00Z
2023-06-12T22:17:17Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/153855
url http://hdl.handle.net/10362/153855
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv von Stosch, M., Hamelink, J. M., & Oliveira, R. (2016). Hybrid modeling as a QbD/PAT tool in process development: an industrial E. coli case study. Bioprocess and Biosystems Engineering, 39(5), 773-784. https://doi.org/10.1007/s00449-016-1557-1
1615-7591
PURE: 14322505
https://doi.org/10.1007/s00449-016-1557-1
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 12
application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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