Table 1.
Luc mRNA-LNP in-use stability at room temperature
| Times (h) | −80°C frozen Luc mRNA-LNPs |
Lyophilized and reconstituted Luc mRNA-LNPs |
||||||
|---|---|---|---|---|---|---|---|---|
| Z-avg (nm) | PDI | [mRNA] mg/mL | % EE | z-avg (nm) | PDI | [mRNA] mg/mL | % EE | |
| 0 | 81 ± 0.6 | 0.07 ± 0.00 | 0.53 ± 0.00 | 97 ± 0.2 | 99 ± 0.6 | 0.07 ± 0.02 | 0.50 ± 0.00 | 95 ± 2.0 |
| 1 | 81 ± 0.9 | 0.06 ± 0.02 | 0.51 ± 0.00 | 97 ± 0.1 | 98 ± 0.3 | 0.07 ± 0.00 | 0.49 ± 0.00 | 93 ± 0.2 |
| 2 | 80 ± 0.0 | 0.09 ± 0.01 | 0.51 ± 0.01 | 97 ± 0.1 | 98 ± 0.3 | 0.05 ± 0.01 | 0.49 ± 0.00 | 93 ± 0.2 |
| 4 | 79 ± 0.3 | 0.09 ± 0.01 | 0.51 ± 0.01 | 97 ± 0.4 | 96 ± 0.6 | 0.08 ± 0.01 | 0.48 ± 0.01 | 93 ± 0.3 |
| 6 | 79 ± 0.7 | 0.08 ± 0.02 | 0.53 ± 0.00 | 97 ± 0.2 | 96 ± 0.7 | 0.07 ± 0.01 | 0.49 ± 0.01 | 92 ± 0.0 |
| 24 | 81 ± 0.3 | 0.08 ± 0.01 | 0.51 ± 0.00 | 97 ± 0.1 | 98 ± 0.3 | 0.09 ± 0.01 | 0.50 ± 0.01 | 92 ± 0.3 |
Particle size, polydispersity, mRNA concentration, and encapsulation efficiency of frozen and reconstituted lyophilized Luc mRNA-LNPs were measured at room temperature (25°C) at set time points for 24 h. PDI, polydispersity; EE, encapsulation efficiency.