General Properties | Appearance (color and clarity) | Visual Inspection |
pH | pH Meter | |
Fill Volume | Gravimetrically Determined | |
Visible Particles | Lamp Inspection | |
Sub-visible Particle | Light Obscuration | |
Osmolality | Osmometer | |
Key Physicochemical Properties | Particle Size | Marlven |
PDI | Marlven | |
Zeta Potential | Marlven | |
Content | mRNA Concentration | HPLC/UV/Ribogreen |
Lipid Quantification (4) | UHPLC-CAD | |
Identity | Sequencing | Sanger |
Lipid Identity (4) | UHPLC-CAD | |
mRNA Integrity | CE/HPLC | |
Purity/Impurity | Encapsulation Efficiency | Ribogreen/HPLC |
Organic Solvents (Ethyl Alcohol) | GC | |
Safety | Sterility | Direct Inoculation |
Endotoxin | LAL | |
Bioactivity | In Vitro Potency | FACS/ELSA |
EN
Topping