Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines. Issue 9 (19th December 2021)

• Record Type: Journal Article
• Authors: Raffaele, Jessica; Loughney, John W.; Rustandi, Richard R.
• Editors: Griend, Cari Sänger – van de; Scriba, Gerhard; Wätzig, Hermann
• Is Part Of: Electrophoresis. Volume 43:Issue 9/10(2022)
• Page Start: 1101
• Page End: 1106
• Publication Date: 2021-12-19
• Subjects: Covid‐19 -- Lipid nanoparticles -- Microchip CE -- mRNA vaccine; Electrophoresis -- Periodicals; Electrophoresis -- Periodicals; 541.372
• DOI: 10.1002/elps.202100272
• Languages: English
• ISSNs: 0173-0835

Abstract

Abstract: 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.