ArticleElectrophoresis2019
Development of an imaged capillary isoelectric focusing method for characterizing the surface charge of mRNA lipid nanoparticle vaccines.
Article in Electrophoresis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Challenges and advances in analytical separation techniques for RNA-lipid nanoparticle therapeutics.Analytical and bioanalytical chemistry · 2026Review
- Measuring ethanol clearance in lipid nanoparticles and liposomes by benchtop NMR.Analytical and bioanalytical chemistry · 2026Article
- Innovative design and comprehensive characterization of a valine-enhanced lipid nanoparticle-coated mRNA vaccine targeting the SARS-CoV-2 S-RBD antigen.Scientific reports · 2025Article
- Microfluidic and Turbulent Mixing for mRNA LNP Vaccines.Pharmaceutics · 2025Review
- Exploring imaged capillary isoelectric focusing parameters for enhanced charge variants quality control.Frontiers in chemistry · 2025Review
- A new paradigm for optimized experimental design in cIEF platforms aimed at an accurate robust and reliable mAbs charge-variant assessment.Scientific reports · 2024Article
- Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine.Vaccines · 2024Article
- Determination of lipid content and stability in lipid nanoparticles using ultra high-performance liquid chromatography in combination with a Corona Charged Aerosol Detector.Electrophoresis · 2022Article
- Development of a microchip capillary electrophoresis method for determination of the purity and integrity of mRNA in lipid nanoparticle vaccines.Electrophoresis · 2022Article
- Enabling online determination of the size-dependent RNA content of lipid nanoparticle-based RNA formulations.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2021Article
- Analytical Methods for Characterization of Nanomaterial Surfaces.Analytical chemistry · 2021Review
- Challenging Bioanalyses with Capillary Electrophoresis.Analytical chemistry · 2020Review
- Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lipid nanoparticles (LNPs) have been employed for drug delivery in small molecules, siRNA, mRNA, and pDNA for both therapeutics and vaccines. Characterization of LNPs is challenging because they are heterogeneous mixtures of large complex particles. Many tools for particle size characterization, such as dynamic and static light scattering, have been applied as well as morphology analysis using electron microscopy. CE has been applied for the characterization of many different large particles such as liposomes, polymer, and viruses. However, there have been limited efforts to characterize the surface charge of LNPs and CIEF has not been explored for this type of particle. Typically, LNPs for delivery of oligonucleotides contain at least four different lipids, with at least one being an ionizable cationic lipid. Here, we describe the development of an imaged capillary isoelectric focusing method used to measure the surface charge (i.e., pI) of an LNP-based mRNA vaccine. This method is capable of distinguishing the pI of LNPs manufactured with one or more different ionizable lipids for the purpose of confirming LNP identity in a manufacturing setting. Additionally, the method is quantitative and stability-indicating making it suitable for both process and formulation development.
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