Table 3. Optimal Conditions for saRNA–LNP Formulation with Regards to Cellular Activation or LNP CQAs.
| input | optimal value 1: minimize cellular activation | optimal value 2: maximize cellular activation | optimal value 3: optimize CQAs |
|---|---|---|---|
| phospholipid content (mol %) | 15.9 | 17.5 | 17.5 |
| aqueous-phase pH | 4.53 | 6 | 5.25 |
| ionizable lipid type | ALC-0315 | SM-102 | ALC-0315 |
| ionizable lipid content (mol %) | 45 | 45 | 35 |
| Fixed Parameters | |
| N/P ratio | 10 |
| phospholipid type | DOPE |
| DMG-PEG-2000 content (mol %) | 1.25 |
| total flow rate (mL/min) | 16 |
| ambient temperature during formulation (°C) | 20 |