Table 4.
Stability comparison of lead lyophilized formulations vs POC samples after storage at 37°C for 3 months
| Sample | Particle size change (<50%)a,d | GLA percent loss (<20%)b,d | ID93 percent loss (<20%)c,d |
|---|---|---|---|
| POC | 84% | 48% | 10% |
| TP | 0% | −2% | 17% |
| TT | −1% | 4% | 8% |
| TMP | −1% | 2% | 21% |
| SMP | 1% | 20% | 11% |
| SP | 3% | 7% | 9% |
| ST | −2% | 36% | 9% |
Notes:
a
Z-average diameter change since lyophilization.
b
GLA content change since t = 0.
c
ID93 content change since t = 0.
d
Preset stability criteria for storage at 37°C shown in parentheses.
Abbreviations: POC, proof of concept; GLA, glucopyranosyl lipid adjuvant; TP, trehalose–phosphate; TT, trehalose–Tris; TMP, trehalose–mannitol–phosphate; SMP, sucrose–mannitol–phosphate; SP, sucrose–phosphate; ST, sucrose–Tris.