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Addressing the Cold Reality of mRNA Vaccine Stability

Authors
  • Crommelin, Daan J.A.1
  • Anchordoquy, Thomas J.2
  • Volkin, David B.3
  • Jiskoot, Wim4
  • Mastrobattista, Enrico1
  • 1 Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, (UIPS), Faculty of Science, Utrecht University, Utrecht, the Netherlands
  • 2 Skaggs School of Pharmacy and Pharmaceutical Sciences, Anschutz Medical Campus, University of Colorado, Aurora, CO 80045, USA
  • 3 Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA
  • 4 rsity, Leiden, the Netherlands
Type
Published Article
Journal
Journal of Pharmaceutical Sciences
Publisher
Elsevier
Publication Date
Dec 13, 2020
Volume
110
Issue
3
Pages
997–1001
Identifiers
DOI: 10.1016/j.xphs.2020.12.006
PMID: 33321139
PMCID: PMC7834447
Source
PubMed Central
Keywords
Disciplines
  • Special Topic Commentary
License
Unknown

Abstract

As mRNA vaccines became the frontrunners in late-stage clinical trials to fight the COVID-19 pandemic, challenges surrounding their formulation and stability became readily apparent. In this commentary, we first describe company proposals, based on available public information, for the (frozen) storage of mRNA vaccine drug products across the vaccine supply chain. We then review the literature on the pharmaceutical stability of mRNA vaccine candidates, including attempts to improve their stability, analytical techniques to monitor their stability, and regulatory guidelines covering product characterization and storage stability. We conclude that systematic approaches to identify the key physicochemical degradation mechanism(s) of formulated mRNA vaccine candidates are currently lacking. Rational design of optimally stabilized mRNA vaccine formulations during storage, transport, and administration at refrigerated or ambient temperatures should thus have top priority in the pharmaceutical development community. In addition to evidence of human immunogenicity against multiple viral pathogens, including compelling efficacy results against COVID-19, another key strength of the mRNA vaccine approach is that it is readily adaptable to rapidly address future outbreaks of new emerging infectious diseases. Consequently, we should not wait for the next pandemic to address and solve the challenges associated with the stability and storage of formulated mRNA vaccines.

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