Challenges in Measuring In Vitro Activity of LNP-mRNA Therapeutics
MRNA-based therapeutics and vaccines represent a rapidly expanding frontier in biomedical innovation, with lipid nanoparticles (LNPs) serving as a clinically validated delivery platform. This study explores critical quality attributes of LNP-mRNA formulations, with a particular focus on in vitro biological activity, a key quality attribute of vaccine activity and batch-to-batch consistency. We discuss the importance of optimizing both LNP components and mRNA structure, highlighting recent advances in formulation strategies. Furthermore, we examine the influence of factors such as cell-line selection, experimental design, storage conditions, and targeted cellular delivery on transduction efficiency. Our findings underscore the need for standardized in vitro assays and process-integrated monitoring to support the scalable development and regulatory assessment of mRNA-based therapies.
GUERRINI Giuditta;
SCACCABAROZZI Diletta;
MĖHN Dóra;
SARRACINO Ambra;
GIORIA Sabrina;
CALZOLAI Luigi;
2025-11-18
MDPI
JRC142873
1422-0067 (online),
https://www.mdpi.com/1422-0067/26/17/8152,
https://publications.jrc.ec.europa.eu/repository/handle/JRC142873,
10.3390/ijms26178152 (online),
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