Journal: Nanomaterials
Article Title: Identifying Key Factors Affecting mRNA-Lipid Nanoparticles Drug Product Formulation Stability
doi: 10.3390/nano16040268
Figure Lengend Snippet: mRNA purity % and in vitro transfection efficiency of FLuc mRNA–LNPs (F1–F4) in 20 mM and 30 mM Tris + 10% sucrose. Samples were measured at 0, 0.5, 1, 3, 6, and 12 months under four storage temperatures (−80 °C, −20 °C, 5 °C, 25 °C). mRNA purity % was measured by MCE. Transfection efficiency was performed on HEK-293 cells, and the luciferase intensity was measured at 24 h post-treatment. For transfection, the data are mean ± SD ( n ≥ 3). At 12-month timepoints, no statistical significance was observed between 20 mM and 30 mM Tris corresponding samples in transfection efficiency results. (One-way ANOVA, p -value > 0.05). For mRNA purity, the data are the means of 3 repeated measures. Note: the time-zero FLuc mRNA purity is <100% due to inherent in vitro transcribed mRNA drug substance heterogeneity and drug substance handling (one freeze–thaw cycle) prior to LNP preparation. F—Formulation; FLuc—Firefly luciferase; LNP—Lipid nanoparticles; MCE—Microchip capillary electrophoresis; MLI—Mean luminescence intensity; mRNA—Messenger ribonucleic acid; SD—Standard deviation.
Article Snippet: HEK-293 cells (CRL-1573) procured from ATCC (Manassas, VA, USA) were grown in Dulbecco’s Modified Eagle’s Medium (DMEM, CAS# 2025-01-30).
Techniques: In Vitro, Transfection, Luciferase, Formulation, MicroChIP Assay, Electrophoresis, Standard Deviation