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Challenges in Measuring In Vitro Activity of LNP-mRNA Therapeutics
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DOI：10.3390-ijms26178152.png)
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Abstract
En 中文
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.
Keywords:
mRNA-based therapeutics
lipid nanoparticles
quality attributes
in vitro biological activity
formulation optimization
Journal
IF:
4.9
Papers:
1.9W
Citations:
44.5W
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