Impact of mixing and shaking on mRNA-LNP drug product quality characteristics
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Publisher
Springer Science and Business Media LLC
Link
https://www.nature.com/articles/s41598-024-70680-4.pdf
Reference19 articles.
1. Vogel, A. B. et al. BNT162b vaccines protect rhesus macaques from SARS-CoV-2. Nature 592, 283–289. https://doi.org/10.1038/s41586-021-03275-y (2021).
2. Corbett, K. S. et al. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. New Engl. J. Med. 383, 1544–1555. https://doi.org/10.1056/NEJMoa2024671 (2020).
3. Akinc, A. et al. The Onpattro story and the clinical translation of nanomedicines containing nucleic acid-based drugs. Nat. Nanotechnol. 14, 1084–1087. https://doi.org/10.1038/s41565-019-0591-y (2019).
4. Packer, M., Gyawali, D., Yerabolu, R., Schariter, J. & White, P. A novel mechanism for the loss of mRNA activity in lipid nanoparticle delivery systems. Nat. Commun. 12, 6777. https://doi.org/10.1038/s41467-021-26926-0 (2021).
5. Chheda, U. et al. Factors affecting stability of RNA – temperature, length, concentration, pH, and buffering species. J. Pharm. Sci. 113, 377–385. https://doi.org/10.1016/j.xphs.2023.11.023 (2024).
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