Advanced Quality and Comparability Assessment of mRNA-Loaded Lipid Nanoparticles: Absolute Size Distribution Profiles and Structure from AF4-Coupled Light and X-ray Scattering Measurements.

ABSTRACT: The success of mRNA lipid nanoparticles (LNPs) used in the COVID-19 vaccines has demonstrated the significance of pharmaceutical products utilizing nanoparticle-based drug delivery systems in global healthcare. For the assessment of the safety, efficacy, and quality of these complex, multicomponent systems, it is important to consider not only the properties of the individual components but also their colloidal organization. There is a need for standardized methods to fulfill requirements for application in regular quality control, providing information on these properties in pharmaceutical products. To gain insight into size and size-resolved quality attributes of LNPs, we apply asymmetrical flow field-flow fractionation (AF4) coupled in-line with synchrotron small-angle X-ray scattering

SUBMITTER: Kolb B 

PROVIDER: S-EPMC12937060 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature