Table 1.
Critical quality controls in the preparation of mRNA drugs
| Composition | Quality control items | Outcome |
|---|---|---|
| Antigen-encoded mRNA | Codon optimization | Translation efficiency |
| Nucleic acid quantity | Translation efficiency | |
| pH at mRNA synthesis stage | Translation efficiency | |
| mRNA sequence identity | Translation efficiency | |
| mRNA sequence integrity | Translation efficiency | |
| Poly A tail length | Translation efficiency | |
| Efficiency of 5′ caping | Translation efficiency | |
| 5′-UTRs and 3′-UTRs optimization | Translation efficiency | |
| mRNA purity | Translation efficiency | |
| Residual DNA template | Translation efficiency | |
| Lipid delivery system | Mass spectrometry analysis | Transfection efficiency |
| Nuclear magnetic resonance analysis | Transfection efficiency | |
| Lipid component identities | Transfection efficiency | |
| Lipid electric charge | Targeting | |
| Lipid ratios | Targeting | |
| Isoelectric point | Stability | |
| Micromorphology | Uniformity | |
| Lipid impurities | Transfection efficiency | |
| Distribution | Targeting | |
| Transfection efficiency in vivo | Transfection efficiency | |
| Transfection efficiency in vitro | Transfection efficiency | |
| mRNA-lipid nanoparticle drugs | Encapsulation efficiency | Loading capacity |
| Particle size | Uniformity | |
| Zeta potential | Stability | |
| Storage conditions | Clinical application | |
| Release principle | Therapeutic potential |