Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography

Detalhes bibliográficos
Autor(a) principal: Vetter, Florian Lukas
Data de Publicação: 2022
Outros Autores: Zobel-Roos, Steffen, Mota, José Paulo Barbosa, Nilsson, Bernt, Schmidt, Axel, Strube, Jochen
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/150717
Resumo: Funding Information: This research was funded by the Institute for Separation and Process Technology from Clausthal University of Technology and received no external funding. Funding Information: The authors would like to acknowledge their institute’s laboratory colleagues, especially Frank Steinhäuser, Nils Hoffmann and Volker Strohmeyer as well as the PCS team Thomas Knebel with Christian Siemers, Automation Technology for the longterm cooperation, and Christian Bohn, Control Engineering, with his co-workers Mirjam Holm and Stephan Beitler at Clausthal University of Technology for PID controller design method support. We kindly acknowledge the support of Open Access Publishing Fund of the Clausthal University of Technology. Publisher Copyright: © 2022 by the authors.
id RCAP_300c05bff8e6d2503df78a7543c16ea7
oai_identifier_str oai:run.unl.pt:10362/150717
network_acronym_str RCAP
network_name_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository_id_str 7160
spelling Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatographyadvanced process controlautomationcontinuous bioprocessingcontinuous chromatographymanufacturingmRNA therapeuticsprocess analytical technologyquality by designBioengineeringChemical Engineering (miscellaneous)Process Chemistry and TechnologySDG 3 - Good Health and Well-beingFunding Information: This research was funded by the Institute for Separation and Process Technology from Clausthal University of Technology and received no external funding. Funding Information: The authors would like to acknowledge their institute’s laboratory colleagues, especially Frank Steinhäuser, Nils Hoffmann and Volker Strohmeyer as well as the PCS team Thomas Knebel with Christian Siemers, Automation Technology for the longterm cooperation, and Christian Bohn, Control Engineering, with his co-workers Mirjam Holm and Stephan Beitler at Clausthal University of Technology for PID controller design method support. We kindly acknowledge the support of Open Access Publishing Fund of the Clausthal University of Technology. Publisher Copyright: © 2022 by the authors.mRNA-based therapeutics are predicted to have a bright future. Recently, a B2C study was published highlighting the critical bottlenecks of mRNA manufacturing. The study focused on supply bottlenecks of various chemicals as well as shortages of skilled personnel. The assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows the need for continuous manufacturing processes that are capable of about 80% chemical reduction and more than 70% personnel at factor five more efficient equipment utilization. The key technology to solve these problems is both a higher degree of automation and the maximization of process throughput. In this paper, the application of a quality-by-design process development approach is demonstrated, using process models as digital twins. Their systematic application leads to both robust optimized process parameters, with an increase in productivity of up to 108%, and sophisticated control concepts, preventing batch failures and minimizing the operating workload in terms of personnel and chemicals’ consumption. The approach thereby provides a data-driven decision basis for the industrialization of such processes, which fulfills the regulatory requirements of the approval authorities and paves the way for PAT integration. In the process investigated, it was shown that conventional PID-based controls can regulate fluctuations in the input streams sufficiently well. Model-based control based on digital twins may have potential above all in a further increase in productivity, but is not mandatory to implement for the industrialization of continuous mRNA manufacturing.LAQV@REQUIMTEDQ - Departamento de QuímicaRUNVetter, Florian LukasZobel-Roos, SteffenMota, José Paulo BarbosaNilsson, BerntSchmidt, AxelStrube, Jochen2023-03-16T22:37:10Z2022-09-152022-09-15T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article21application/pdfhttp://hdl.handle.net/10362/150717engVetter, F. L., Zobel-Roos, S., Mota, J. P. B., Nilsson, B., Schmidt, A., & Strube, J. (2022). Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography. Processes, 10(9), [1868]. https://doi.org/10.3390/pr100918682227-9717PURE: 56086853https://doi.org/10.3390/pr10091868info: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:RCAAP2024-03-11T05:33:03Zoai:run.unl.pt:10362/150717Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:54:16.544858Repositório 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 Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
title Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
spellingShingle Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
Vetter, Florian Lukas
advanced process control
automation
continuous bioprocessing
continuous chromatography
manufacturing
mRNA therapeutics
process analytical technology
quality by design
Bioengineering
Chemical Engineering (miscellaneous)
Process Chemistry and Technology
SDG 3 - Good Health and Well-being
title_short Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
title_full Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
title_fullStr Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
title_full_unstemmed Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
title_sort Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography
author Vetter, Florian Lukas
author_facet Vetter, Florian Lukas
Zobel-Roos, Steffen
Mota, José Paulo Barbosa
Nilsson, Bernt
Schmidt, Axel
Strube, Jochen
author_role author
author2 Zobel-Roos, Steffen
Mota, José Paulo Barbosa
Nilsson, Bernt
Schmidt, Axel
Strube, Jochen
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv LAQV@REQUIMTE
DQ - Departamento de Química
RUN
dc.contributor.author.fl_str_mv Vetter, Florian Lukas
Zobel-Roos, Steffen
Mota, José Paulo Barbosa
Nilsson, Bernt
Schmidt, Axel
Strube, Jochen
dc.subject.por.fl_str_mv advanced process control
automation
continuous bioprocessing
continuous chromatography
manufacturing
mRNA therapeutics
process analytical technology
quality by design
Bioengineering
Chemical Engineering (miscellaneous)
Process Chemistry and Technology
SDG 3 - Good Health and Well-being
topic advanced process control
automation
continuous bioprocessing
continuous chromatography
manufacturing
mRNA therapeutics
process analytical technology
quality by design
Bioengineering
Chemical Engineering (miscellaneous)
Process Chemistry and Technology
SDG 3 - Good Health and Well-being
description Funding Information: This research was funded by the Institute for Separation and Process Technology from Clausthal University of Technology and received no external funding. Funding Information: The authors would like to acknowledge their institute’s laboratory colleagues, especially Frank Steinhäuser, Nils Hoffmann and Volker Strohmeyer as well as the PCS team Thomas Knebel with Christian Siemers, Automation Technology for the longterm cooperation, and Christian Bohn, Control Engineering, with his co-workers Mirjam Holm and Stephan Beitler at Clausthal University of Technology for PID controller design method support. We kindly acknowledge the support of Open Access Publishing Fund of the Clausthal University of Technology. Publisher Copyright: © 2022 by the authors.
publishDate 2022
dc.date.none.fl_str_mv 2022-09-15
2022-09-15T00:00:00Z
2023-03-16T22:37:10Z
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/10362/150717
url http://hdl.handle.net/10362/150717
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Vetter, F. L., Zobel-Roos, S., Mota, J. P. B., Nilsson, B., Schmidt, A., & Strube, J. (2022). Toward Autonomous Production of mRNA-Therapeutics in the Light of Advanced Process Control and Traditional Control Strategies for Chromatography. Processes, 10(9), [1868]. https://doi.org/10.3390/pr10091868
2227-9717
PURE: 56086853
https://doi.org/10.3390/pr10091868
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 21
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
repository.mail.fl_str_mv
_version_ 1799138131927105536

Registros relacionados