Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts

SARS-COVID-19 vaccine supply for the total worldwide population has a bottleneck in manufacturing capacity. Assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows a need for digital twins enabled by process analytical technology approaches in order to improve process trans...

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Autores principales:	Axel Schmidt, Heribert Helgers, Florian Lukas Vetter, Alex Juckers, Jochen Strube
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	mRNA pDNA SARS-COVID-19 vaccines digital twin process analytical technology Chemical technology TP1-1185 Chemistry QD1-999
Acceso en línea:	https://doaj.org/article/36df35f292794daaa354e627e9a63b18
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spelling	oai:doaj.org-article:36df35f292794daaa354e627e9a63b182021-11-25T18:49:58ZFast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts10.3390/pr91118742227-9717https://doaj.org/article/36df35f292794daaa354e627e9a63b182021-10-01T00:00:00Zhttps://www.mdpi.com/2227-9717/9/11/1874https://doaj.org/toc/2227-9717SARS-COVID-19 vaccine supply for the total worldwide population has a bottleneck in manufacturing capacity. Assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows a need for digital twins enabled by process analytical technology approaches in order to improve process transfer for manufacturing capacity multiplication, a reduction in out-of-specification batch failures, qualified personal training for faster validation and efficient operation, optimal utilization of scarce buffers and chemicals and speed-up of product release by continuous manufacturing. In this work, three manufacturing concepts for mRNA-based vaccines are evaluated: Batch, full-continuous and semi-continuous. Technical transfer from batch single-use to semi-continuous stainless-steel, i.e., plasmid deoxyribonucleic acid (pDNA) in batch and mRNA in continuous operation mode, is recommended, in order to gain: faster plant commissioning and start-up times of about 8–12 months and a rise in dose number by a factor of about 30 per year, with almost identical efforts in capital expenditures (CAPEX) and personnel resources, which are the dominant bottlenecks at the moment, at about 25% lower operating expenses (OPEX). Consumables are also reduceable by a factor of 6 as outcome of this study. Further optimization potential is seen at consequent digital twin and PAT (Process Analytical Technology) concept integration as key-enabling technologies towards autonomous operation including real-time release-testing.Axel SchmidtHeribert HelgersFlorian Lukas VetterAlex JuckersJochen StrubeMDPI AGarticlemRNApDNASARS-COVID-19vaccinesdigital twinprocess analytical technologyChemical technologyTP1-1185ChemistryQD1-999ENProcesses, Vol 9, Iss 1874, p 1874 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	mRNA pDNA SARS-COVID-19 vaccines digital twin process analytical technology Chemical technology TP1-1185 Chemistry QD1-999
spellingShingle	mRNA pDNA SARS-COVID-19 vaccines digital twin process analytical technology Chemical technology TP1-1185 Chemistry QD1-999 Axel Schmidt Heribert Helgers Florian Lukas Vetter Alex Juckers Jochen Strube Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts
description	SARS-COVID-19 vaccine supply for the total worldwide population has a bottleneck in manufacturing capacity. Assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows a need for digital twins enabled by process analytical technology approaches in order to improve process transfer for manufacturing capacity multiplication, a reduction in out-of-specification batch failures, qualified personal training for faster validation and efficient operation, optimal utilization of scarce buffers and chemicals and speed-up of product release by continuous manufacturing. In this work, three manufacturing concepts for mRNA-based vaccines are evaluated: Batch, full-continuous and semi-continuous. Technical transfer from batch single-use to semi-continuous stainless-steel, i.e., plasmid deoxyribonucleic acid (pDNA) in batch and mRNA in continuous operation mode, is recommended, in order to gain: faster plant commissioning and start-up times of about 8–12 months and a rise in dose number by a factor of about 30 per year, with almost identical efforts in capital expenditures (CAPEX) and personnel resources, which are the dominant bottlenecks at the moment, at about 25% lower operating expenses (OPEX). Consumables are also reduceable by a factor of 6 as outcome of this study. Further optimization potential is seen at consequent digital twin and PAT (Process Analytical Technology) concept integration as key-enabling technologies towards autonomous operation including real-time release-testing.
format	article
author	Axel Schmidt Heribert Helgers Florian Lukas Vetter Alex Juckers Jochen Strube
author_facet	Axel Schmidt Heribert Helgers Florian Lukas Vetter Alex Juckers Jochen Strube
author_sort	Axel Schmidt
title	Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts
title_short	Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts
title_full	Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts
title_fullStr	Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts
title_full_unstemmed	Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts
title_sort	fast and flexible mrna vaccine manufacturing as a solution to pandemic situations by adopting chemical engineering good practice—continuous autonomous operation in stainless steel equipment concepts
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/36df35f292794daaa354e627e9a63b18
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Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts

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