Stability modelling of mRNA vaccine quality based on temperature monitoring throughout the distribution chain
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Published version
Author(s)
Kis, Zoltan
Type
Journal Article
Abstract
The vaccine distribution chains in several low- and middle-income countries are not adequate to facilitate the rapid delivery of high volumes of thermosensitive COVID-19 mRNA vaccines at the required low and ultra-low temperatures. COVID-19 mRNA vaccines are currently distributed along with temperature monitoring devices to track and identify deviations from predefined conditions throughout the distribution chain. These temperature readings can feed into computational models to quantify mRNA vaccine critical quality attributes (CQAs) and the remaining vaccine shelf life more accurately. Here, a kinetic modelling approach is proposed to quantify the stability-related CQAs and the remaining shelf life of mRNA vaccines. The CQA and shelf-life values can be computed based on the conditions under which the vaccines have been distributed from the manufacturing facilities via the distribution network to the vaccination centres. This approach helps to quantify the degree to which temperature excursions impact vaccine quality and can also reduce vaccine wastage. In addition, vaccine stock management can be improved due to the information obtained on the remaining shelf life of mRNA vaccines. This model-based quantification of mRNA vaccine quality and remaining shelf life can improve the deployment of COVID-19 mRNA vaccines to low- and middle-income countries.
Date Issued
2022-02-17
Date Acceptance
2022-02-08
Citation
Pharmaceutics, 2022, 14 (2)
ISSN
1999-4923
Publisher
MDPI AG
Journal / Book Title
Pharmaceutics
Volume
14
Issue
2
Copyright Statement
© 2022 by the author.
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/).
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/).
License URL
Sponsor
Engineering and Physical Sciences Research Council (EPSRC)
Grant Number
EP/R013764/1
Subjects
COVID-19
LNP-mRNA
mRNA vaccines
quality by design
stability modelling
stability related CQAs
supply chain
1115 Pharmacology and Pharmaceutical Sciences
Publication Status
Published
Article Number
ARTN 430