Critical Evaluation of Key Methods for RNA Quantification
The approval of safe and effective lipid nanoparticles-encapsulated mRNA (LNP-mRNA) vaccines during the SARS-CoV-2 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 the agreement between different analytical methods.
Authors
- Gabriele Leoni (ORCID: https://orcid.org/0000-0002-4899-5284)
- Mauro Petrillo (ORCID: https://orcid.org/0000-0002-6782-4704)
- Antonio Marchini (ORCID: https://orcid.org/0000-0003-3157-4552)
- Valentina Paracchini (ORCID: https://orcid.org/0000-0002-4847-9992)
- Otmar Geiss (ORCID: https://orcid.org/0000-0002-5371-3798)
- Luigi Calzolai (ORCID: https://orcid.org/0000-0002-8474-7974)
- Giuditta Guerrini (ORCID: https://orcid.org/0000-0002-1446-0556)
- Sabrina Gioria (ORCID: https://orcid.org/0000-0001-7150-9523)
- Luca Fornara
Institutions
- European Commission (BE)
- Eidos (Italy) (IT)
- Joint Research Centre (IT)
Publication Details
- Journal
- International Journal of Molecular Sciences
- Published
- 2026-08-18
- DOI
- https://doi.org/10.3390/ijms27167379
- Primary Topic
- RNA Interference and Gene Delivery
- Type
- article
- Field-Weighted Citation Impact
- 0.00