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Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand
To overcome pandemics, such as COVID-19, vaccines are urgently needed at very high volumes. Here we assess the techno-economic feasibility of producing RNA vaccines for the demand associated with a global vaccination campaign. Production process performance is assessed for three messenger RNA (mRNA)...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824664/ https://www.ncbi.nlm.nih.gov/pubmed/33374802 http://dx.doi.org/10.3390/vaccines9010003 |
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author | Kis, Zoltán Kontoravdi, Cleo Shattock, Robin Shah, Nilay |
author_facet | Kis, Zoltán Kontoravdi, Cleo Shattock, Robin Shah, Nilay |
author_sort | Kis, Zoltán |
collection | PubMed |
description | To overcome pandemics, such as COVID-19, vaccines are urgently needed at very high volumes. Here we assess the techno-economic feasibility of producing RNA vaccines for the demand associated with a global vaccination campaign. Production process performance is assessed for three messenger RNA (mRNA) and one self-amplifying RNA (saRNA) vaccines, all currently under clinical development, as well as for a hypothetical next-generation saRNA vaccine. The impact of key process design and operation uncertainties on the performance of the production process was assessed. The RNA vaccine drug substance (DS) production rates, volumes and costs are mostly impacted by the RNA amount per vaccine dose and to a lesser extent by the scale and titre in the production process. The resources, production scale and speed required to meet global demand vary substantially in function of the RNA amount per dose. For lower dose saRNA vaccines, global demand can be met using a production process at a scale of below 10 L bioreactor working volume. Consequently, these small-scale processes require a low amount of resources to set up and operate. RNA DS production can be faster than fill-to-finish into multidose vials; hence the latter may constitute a bottleneck. |
format | Online Article Text |
id | pubmed-7824664 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-78246642021-01-24 Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand Kis, Zoltán Kontoravdi, Cleo Shattock, Robin Shah, Nilay Vaccines (Basel) Article To overcome pandemics, such as COVID-19, vaccines are urgently needed at very high volumes. Here we assess the techno-economic feasibility of producing RNA vaccines for the demand associated with a global vaccination campaign. Production process performance is assessed for three messenger RNA (mRNA) and one self-amplifying RNA (saRNA) vaccines, all currently under clinical development, as well as for a hypothetical next-generation saRNA vaccine. The impact of key process design and operation uncertainties on the performance of the production process was assessed. The RNA vaccine drug substance (DS) production rates, volumes and costs are mostly impacted by the RNA amount per vaccine dose and to a lesser extent by the scale and titre in the production process. The resources, production scale and speed required to meet global demand vary substantially in function of the RNA amount per dose. For lower dose saRNA vaccines, global demand can be met using a production process at a scale of below 10 L bioreactor working volume. Consequently, these small-scale processes require a low amount of resources to set up and operate. RNA DS production can be faster than fill-to-finish into multidose vials; hence the latter may constitute a bottleneck. MDPI 2020-12-23 /pmc/articles/PMC7824664/ /pubmed/33374802 http://dx.doi.org/10.3390/vaccines9010003 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Kis, Zoltán Kontoravdi, Cleo Shattock, Robin Shah, Nilay Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand |
title | Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand |
title_full | Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand |
title_fullStr | Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand |
title_full_unstemmed | Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand |
title_short | Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand |
title_sort | resources, production scales and time required for producing rna vaccines for the global pandemic demand |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824664/ https://www.ncbi.nlm.nih.gov/pubmed/33374802 http://dx.doi.org/10.3390/vaccines9010003 |
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