ArticleAnalytical and bioanalytical chemistry2024
Development of an advanced separation and characterization platform for mRNA and lipid nanoparticles using multi-detector asymmetrical flow field-flow fractionation.
Article in Analytical and bioanalytical chemistry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Elucidating lipid nanoparticle properties and structure through biophysical analyses.Nature biotechnology · 2026Article
- Analytical Characterization and Stability Assessment of RNA-Based Vaccines.Pharmaceutics · 2026Review
- Challenges and advances in analytical separation techniques for RNA-lipid nanoparticle therapeutics.Analytical and bioanalytical chemistry · 2026Review
- Elucidating lipid nanoparticle properties and structure through biophysical analyses.bioRxiv : the preprint server for biology · 2025Article
- Microfluidic Nanoparticle Separation for Precision Medicine.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Review
- Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
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Authors and funding
8 authors.
Funding
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Abstract
In recent years, the use of lipid nanoparticles (LNPs) for delivery of messenger RNA (mRNA)-based therapies has gained substantial attention in the field of drug development. In such an application, multiple LNP attributes have to be carefully characterized to ensure product safety and quality, whereas accurate and efficient characterization of these complex mRNA-LNP formulations remains a challenging endeavor. Here, we present the development and application of an online separation and characterization platform designed for the isolation and in-depth analysis of mRNAs and mRNA-loaded LNPs. Our asymmetrical flow field-flow fractionation with a multi-detector (MD-AF4) method has demonstrated exceptional resolution between mRNA-LNPs and mRNAs, delivering excellent recoveries (over 70%) for both analytes and exceptional repeatability. Notably, this platform allows for comprehensive and multi-attribute LNP characterization, including online particle sizing, morphology characterization, and determination of encapsulation efficiency, all within a single injection. Furthermore, real-time online sizing by synchronizing multi-angle light scattering (MALS) and dynamic light scattering (DLS) presented higher resolution over traditional batch-mode DLS, particularly in differentiating heterogeneous samples with a low abundance of large-sized particles. Additionally, our method proves to be a valuable tool for monitoring LNP stability under varying stress conditions. Our work introduces a robust and versatile analytical platform using MD-AF4 that not only efficiently provides multi-attribute characterizations of mRNA-LNPs but also holds promise in advancing studies related to formulation screening, quality control, and stability assessment in the evolving field of nanoparticle delivery systems for mRNAs.
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Registered trials
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