Analytical techniques for the characterization of nanoparticles for mRNA delivery
Eur J Pharm Biopharm. 2024 Feb 22:114235. doi: 10.1016/j.ejpb.2024.114235. Online ahead of print.ABSTRACTNanotechnology-assisted RNA delivery has gotten a tremendous boost over the last decade and made a significant impact in the development of life-changing vaccines and therapeutics. With increasing numbers of emerging lipid- and polymer-based RNA nanoparticles progressing towards the clinic, it has become apparent that the safety and efficacy of these medications depend on the comprehensive understanding of their critical quality attributes (CQAs). However, despite the rapid advancements in the field, the identification and reliable quantification of CQAs remain a significant challenge. To support these efforts, this review aims to summarize the present knowledge on CQAs based on the regulatory guidelines and to provide insights into the available analytical characterization techniques for RNA-loaded nanoparticles. In this context, routine and emerging analytical techniques are categorized and discussed, focusing on the operation principle, strengths, and potential limitations. Furthermore, the importance of complementary and orthogonal techniques for the measurement of CQAs is discussed in order to ensure the quality and consistency of analytical methods used, and address potential technique-based differences.PMID:38401742 | DOI:10.1016/j.ejpb.2024.114235
Source: European Journal of Pharmaceutics and Biopharmaceutics - Category: Drugs & Pharmacology Authors: Sara S Nogueira Eleni Samaridou Johanna Simon Simon Frank Moritz Beck-Broichsitter Aditi Mehta Source Type: research