Rapid development and deployment of high-volume
vaccines for pandemic response
vaccines for pandemic response
File(s)amp2.10060.pdf (2.28 MB)
Published version
Author(s)
Kis, Zoltan
Kontoravdi, Kleio
Dey, Antu K
Shattock, Robin
Shah, Nilay
Type
Journal Article
Abstract
Overcoming pandemics, such as the current Covid‐19 outbreak, requires the manufacture of several billion doses of vaccines within months. This is an extremely challenging task given the constraints in small‐scale manufacturing for clinical trials, clinical testing timelines involving multiple phases and large‐scale drug substance and drug product manufacturing. To tackle these challenges, regulatory processes are fast‐tracked, and rapid‐response manufacturing platform technologies are used. Here, we evaluate the current progress, challenges ahead and potential solutions for providing vaccines for pandemic response at an unprecedented scale and rate. Emerging rapid‐response vaccine platform technologies, especially RNA platforms, offer a high productivity estimated at over 1 billion doses per year with a small manufacturing footprint and low capital cost facilities. The self‐amplifying RNA (saRNA) drug product cost is estimated at below 1 USD/dose. These manufacturing processes and facilities can be decentralized to facilitate production, distribution, but also raw material supply. The RNA platform technology can be complemented by an a priori Quality by Design analysis aided by computational modeling in order to assure product quality and further speed up the regulatory approval processes when these platforms are used for epidemic or pandemic response in the future.
Date Issued
2020-07-13
Date Acceptance
2020-06-01
Citation
Journal of Advanced Manufacturing and Processing, 2020, 2 (3), pp.1-10
ISSN
2637-403X
Publisher
Wiley-Blackwell
Start Page
1
End Page
10
Journal / Book Title
Journal of Advanced Manufacturing and Processing
Volume
2
Issue
3
Copyright Statement
© 2020 The Authors. Journal of Advanced Manufacturing and Processing published by Wiley Periodicals LLC. on behalf of American Institute of Chemical Engineers
This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
License URL
Sponsor
Engineering & Physical Science Research Council (EPSRC)
Identifier
https://aiche.onlinelibrary.wiley.com/doi/full/10.1002/amp2.10060
Grant Number
EP/R013764/1
Publication Status
Published
Date Publish Online
2020-06-29