Addressing the Cold Reality of mRNA Vaccine Stability

Journal of Pharmaceutical Sciences - Tập 110 - Trang 997-1001 - 2021
Daan J.A. Crommelin1, Thomas J. Anchordoquy2, David B. Volkin3, Wim Jiskoot4, Enrico Mastrobattista1
1Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht University, Utrecht, the Netherlands
2Skaggs School of Pharmacy and Pharmaceutical Sciences, Anschutz Medical Campus, University of Colorado, Aurora, CO 80045, USA
3Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, Lawrence, KS 66047, USA
4Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.

Tài liệu tham khảo

Hrabovszki Kansteiner Pollard, 2013, Challenges and advances towards the rational design of mRNA vaccines, Trends Mol Med, 19, 705, 10.1016/j.molmed.2013.09.002 Kowalski, 2019, Delivering the messenger: advances in technologies for therapeutic mRNA delivery, Mol Ther, 27, 710, 10.1016/j.ymthe.2019.02.012 Pardi, 2018, mRNA vaccines - a new era in vaccinology, Nat Rev Drug Discov, 17, 261, 10.1038/nrd.2017.243 Pogocki, 2000, Chemical stability of nucleic acid–derived drugs, J Pharm Sci, 89, 443, 10.1002/(SICI)1520-6017(200004)89:4<443::AID-JPS2>3.0.CO;2-W Mikkola, 2001, The effect of secondary structure on cleavage of the phosphodiester bonds of RNA, Cell Biochem Biophys, 34, 95, 10.1385/CBB:34:1:95 Wayment-Steele, 2020, Theoretical basis for stabilizing messenger RNA through secondary structure design, bioRxiv Reichmuth, 2016, mRNA vaccine delivery using lipid nanoparticles, Ther Deliv, 7, 319, 10.4155/tde-2016-0006 Hassett, 2019, Optimization of lipid nanoparticles for intramuscular administration of mRNA vaccines, Mol Ther Nucleic Acids, 15, 1, 10.1016/j.omtn.2019.01.013 Lutz, 2017, Unmodified mRNA in LNPs constitutes a competitive technology for prophylactic vaccines, NPJ Vaccines, 2, 10.1038/s41541-017-0032-6 Sedic, 2018, Safety evaluation of lipid nanoparticle-formulated modified mRNA in the sprague-dawley rat and cynomolgus monkey, Vet Pathol, 55, 341, 10.1177/0300985817738095 Paris Kaczmarek, 2017, Advances in the delivery of RNA therapeutics: from concept to clinical reality, Genome Med, 9, 10.1186/s13073-017-0450-0 Muralidhara, 2016, Critical considerations for developing nucleic acid macromolecule based drug products, Drug Discov Today, 21, 430, 10.1016/j.drudis.2015.11.012 Jones, 2007, Long-term storage of DNA-free RNA for use in vaccine studies, Biotechniques, 43, 675, 10.2144/000112593 Stitz, 2017, A thermostable messenger RNA based vaccine against rabies, PLoS Negl Trop Dis, 11, e0006108, 10.1371/journal.pntd.0006108 Mutzke Mutzke Ketterer Panah Kievits Zhao, 2020, Long-term storage of lipid-like nanoparticles for mRNA delivery, Bioact Mater, 5, 358, 10.1016/j.bioactmat.2020.03.001 Naik, 2020, Regulatory considerations on the development of mRNA vaccines, 1, 10.1007/82_2020_220 Hinz, 2017, The European regulatory environment of RNA-based vaccines, 203 Schmid, 2017, Considerations for producing mRNA vaccines for clinical trials, 237 Poveda, 2019, Establishing preferred product characterization for the evaluation of RNA vaccine antigens, Vaccines (Basel), 7 Patel, 2017, Boosting intracellular delivery of lipid nanoparticle-encapsulated mRNA, Nano Lett, 17, 5711, 10.1021/acs.nanolett.7b02664 Middaugh, 2007, Analysis of cationic-lipid-plasmid-DNA complexes, Anal Chem, 79, 7240, 10.1021/ac0719711