Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand
1
Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London SW7 2AZ, UK
2
Department of Infectious Disease, Faculty of Medicine, Imperial College London, London W2 1PG, UK
*
Author to whom correspondence should be addressed.
Vaccines 2021, 9(1), 3; https://doi.org/10.3390/vaccines9010003
Received: 1 December 2020 / Revised: 17 December 2020 / Accepted: 19 December 2020 / Published: 23 December 2020
(This article belongs to the Special Issue The Past, Present, and Future of mRNA Vaccines)
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.
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Keywords:
RNA vaccines; mRNA vaccines; saRNA vaccines; pandemic-response vaccine production; COVID-19; production process modelling; techno-economic analysis
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MDPI and ACS Style
Kis, Z.; Kontoravdi, C.; Shattock, R.; Shah, N. Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand. Vaccines 2021, 9, 3. https://doi.org/10.3390/vaccines9010003
AMA Style
Kis Z, Kontoravdi C, Shattock R, Shah N. Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand. Vaccines. 2021; 9(1):3. https://doi.org/10.3390/vaccines9010003
Chicago/Turabian StyleKis, Zoltán; Kontoravdi, Cleo; Shattock, Robin; Shah, Nilay. 2021. "Resources, Production Scales and Time Required for Producing RNA Vaccines for the Global Pandemic Demand" Vaccines 9, no. 1: 3. https://doi.org/10.3390/vaccines9010003
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