Work

Challenges in Measuring In Vitro Activity of LNP-mRNA Therapeutics

Year: 2025

Type: article

Abstract: 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.

Source: International Journal of Molecular Sciences

DOI: 10.3390/ijms26178152

Authors: Giuditta Guerrini, Diletta Scaccabarozzi, Dora Mehn, Ambra Sarracino, Sabrina Gioria, Luigi Calzolai

Institution: Joint Research Centre

Language: English

Topic: RNA Interference and Gene Delivery

Subfield: Molecular Biology

Field: Biochemistry, Genetics and Molecular Biology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,499