The approval of safe and effective Lipid Nanoparticles encapsulated mRNA (LNP-mRNA) vaccines during the SARS
CoV2 pandemic is catalysing the development of the next generation of mRNA therapeutics. Accurate characterisation
methods are crucial for assessing the quality and efficacy of these complex formulations. Several analytical techniques
exist for the quantification of the mRNA drug substance, including UV spectroscopy, capillary electrophoresis, high
performance liquid chromatography (HPLC), and digital PCR (dPCR). Here, we compare these methods, highlight their
limitations, and discuss critical considerations for experimental design to improve analytical accuracy.
PARACCHINI Valentina;
PETRILLO Mauro;
FORNARA Luca;
GIORIA Sabrina;
LEONI Gabriele;
GUERRINI Giuditta;
GEISS Otmar;
MARCHINI Antonio;
CALZOLAI Luigi;
2026-09-22
MDPI
JRC147725
1422-0067 (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC147725,
10.3390/ijms27167379 (online),
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