Resources, production scales and time required for producing RNA vaccines for the global pandemic demand.
File(s)
Published version
Author(s)
Kis, Zoltán
Kontoravdi, Cleo
Shattock, Robin
Shah, Nilay
Type
Journal Article
Abstract
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.
Date Issued
2020-12-23
Date Acceptance
2020-12-19
Citation
Vaccines (Basel), 2020, 9 (1), pp.1-14
ISSN
2076-393X
Start Page
1
End Page
14
Journal / Book Title
Vaccines (Basel)
Volume
9
Issue
1
Copyright Statement
© 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 (https://creativecommons.org/licenses/by/4.0/).
article is an open access article distributed
under the terms and conditions of the
Creative Commons Attribution (CC BY)
license (https://creativecommons.org/licenses/by/4.0/).
License URL
Sponsor
Engineering and Physical Sciences Research Council (EPSRC)
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/33374802
PII: vaccines9010003
Grant Number
EP/R013764/1
Subjects
COVID-19
RNA vaccines
mRNA vaccines
pandemic-response vaccine production
production process modelling
saRNA vaccines
techno-economic analysis
Publication Status
Published
Coverage Spatial
Switzerland
Date Publish Online
2020-12-23