ArticleAnalytical chemistry2025
Proof of Concept Application of Hydrophilic Interaction Chromatography for Direct Online Disruption of Lipid Nanoparticles, Intact mRNA Analysis, and Measure of Encapsulation Efficiency.
Article in Analytical chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Self-amplifying RNA (saRNA) and circular RNA (circRNA) vaccines: Progress, evidence gaps, and translational pathways for durable and scalable immunization.Human vaccines & immunotherapeutics · 2026Review
- Challenges and advances in analytical separation techniques for RNA-lipid nanoparticle therapeutics.Analytical and bioanalytical chemistry · 2026Review
- Challenges and advances in analytical separation techniques for RNA-lipid nanoparticle therapeutics.Analytical and bioanalytical chemistry · 2026Review
- Anion Exchange Chromatography to Determine mRNA Encapsulation in Lipid Nanoparticles.Analytical chemistry · 2025Article
- Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lipid nanoparticles (LNPs) are a key platform for delivering mRNA vaccines and therapeutics with numerous innovative drugs under development. However, characterizing these complex and unstable products remains challenging. Developing fast, reliable methods to assess critical quality attributes (CQAs) of the mRNA component is crucial for ensuring the safety and efficacy of these medicines. Currently, evaluating key CQAs, such as mRNA integrity and encapsulation efficiency, often involves a labor-intensive manual extraction protocol, which requires LNP disruption prior to analysis. However, these additional offline steps contribute to mRNA degradation and measurement uncertainties, highlighting the urgent need for rapid and effective methods capable of performing an online LNP disruption. Hydrophilic interaction chromatography (HILIC) might offer a promising solution to address this need. Due to the presence of high concentrations of organic solvent and the possibility to work at elevated temperatures, HILIC might enable on-column disruption of LNPs while preserving the full integrity of the mRNA payload, facilitating a streamlined characterization process. To evaluate this, we developed two proof of concept HILIC methods. The first one disrupts LNPs and retains the mRNA payload using a high percentage of organic solvent and elevated temperatures. The second one, relying on milder conditions, retains only the unencapsulated mRNA, which can be used to evaluate the encapsulation efficiency. Both methods were used on Comirnaty and Spikevax vaccines and on Sanofi's in-development mRNA product as model samples. Our preliminary findings suggest that HILIC holds potential for online LNP disruption, mRNA integrity assessment, and encapsulation efficiency analysis. They also highlight the limitations of small-pore-sized columns currently available on the market.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.