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Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines

Messenger RNA (mRNA)‐based vaccines are advantageous because they can be relatively quicker and more cost efficient to manufacture compared to other traditional vaccine products. Lipid nanoparticles have three common purposes: delivery, self‐adjuvanting properties, and mRNA protection. Faster vaccin...

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Detalles Bibliográficos
Autores principales: Raffaele, Jessica, Loughney, John W., Rustandi, Richard R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9011815/
https://www.ncbi.nlm.nih.gov/pubmed/34806186
http://dx.doi.org/10.1002/elps.202100272
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author Raffaele, Jessica
Loughney, John W.
Rustandi, Richard R.
author_facet Raffaele, Jessica
Loughney, John W.
Rustandi, Richard R.
author_sort Raffaele, Jessica
collection PubMed
description Messenger RNA (mRNA)‐based vaccines are advantageous because they can be relatively quicker and more cost efficient to manufacture compared to other traditional vaccine products. Lipid nanoparticles have three common purposes: delivery, self‐adjuvanting properties, and mRNA protection. Faster vaccine development requires an efficient and fast assay to monitor mRNA purity and integrity. Microchip CE is known to be a robust technology that is capable of rapid separation. Here, we describe the development and optimization of a purity and integrity assay for mRNA‐based vaccines encapsulated in lipid nanoparticles using commercial microchip‐based separation. The analytical parameters of the optimized assay were assessed and the method is a stability indicating assay.
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spelling pubmed-90118152022-04-15 Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines Raffaele, Jessica Loughney, John W. Rustandi, Richard R. Electrophoresis Vaccines Messenger RNA (mRNA)‐based vaccines are advantageous because they can be relatively quicker and more cost efficient to manufacture compared to other traditional vaccine products. Lipid nanoparticles have three common purposes: delivery, self‐adjuvanting properties, and mRNA protection. Faster vaccine development requires an efficient and fast assay to monitor mRNA purity and integrity. Microchip CE is known to be a robust technology that is capable of rapid separation. Here, we describe the development and optimization of a purity and integrity assay for mRNA‐based vaccines encapsulated in lipid nanoparticles using commercial microchip‐based separation. The analytical parameters of the optimized assay were assessed and the method is a stability indicating assay. John Wiley and Sons Inc. 2021-12-19 2022-05 /pmc/articles/PMC9011815/ /pubmed/34806186 http://dx.doi.org/10.1002/elps.202100272 Text en © 2021 Merck Sharp & Dohme Corp. Electrophoresis published by Wiley‐VCH GmbH. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Vaccines
Raffaele, Jessica
Loughney, John W.
Rustandi, Richard R.
Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines
title Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines
title_full Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines
title_fullStr Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines
title_full_unstemmed Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines
title_short Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines
title_sort development of a microchip capillary electrophoresis method for determination of the purity and integrity of mrna in lipid nanoparticle vaccines
topic Vaccines
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9011815/
https://www.ncbi.nlm.nih.gov/pubmed/34806186
http://dx.doi.org/10.1002/elps.202100272
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