Table 1. Input and Outputs from Iteration A.
| experimental
inputs | |||
|---|---|---|---|
| factor | levels | ||
| N/P ratio | 5 | 10 | 15 |
| phospholipid type | DOPE | DSPC | |
| phospholipid content (mol %) | 10 | 15 | 20 |
| ionizable lipid type (corresponding pKa) | DLin-MC3-DMA (6.4) | ALC-0315 (6.09) | SM-102 (6.75) |
| ionizable lipid content (mol %) | 30 | 40 | 50 |
| DMG-PEG-2000 content (mol %) | 0 | 1.25 | 2.5 |
| total flow rate | 2 mL/min | 9 mL/min | 16 mL/min |
| ambient temperature during formulation (°C) | 4 | 20 | 37 |
| aqueous-phase pH | 3 | 5 | 7 |
| RNA type | mRNA | saRNA | |
| experimental
outputs | |
|---|---|
| critical quality attributes | analytical method |
| size | dynamic light scattering |
| PDI | dynamic light scattering |
| EE | RiboGreen assay |
| charge | dynamic light scattering |
| % filled particles | RiboGreen assay/nanoparticle tracking analysis |
| % full RNA transcripts | BioAnalyzer |