Table 1.
Stability of the PRIMVAC drug product at −20 °C and 3 0°C.
| −20 °C |
30 °C |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| TESTS | Specifications | T0-released batch | 3 months | 6 months | 9 months | 12 months | 18 months | 24 months | 36 months | 7 days |
| Visual appearence | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles | Clear, colorless liquid w/o visible particles |
| pH | 6.5 to 8.0 | 7.1 | 7.2 | 7.2 | 7.2 | 7.3 | 7.2 | 7.2 | 7.2 | 7.2 |
| Profile by SDS-PAGE | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDaa |
| Identity by Western Blot (R and NR conditions) | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa | One major band at 100 kDa |
| Purity by RP-HPLC | Main peak ≥95% | 99.7% | 99.66% | 99.65% | 99.65% | 99.64% | 99.61% | 99.5% | 99.5% | 99.71% |
| Residual DNA | <200 ng/mg | 5 ng/mg | ND | ND | ND | ND | ND | ND | ND | ND |
| Host cell proteins | ≤1% | <1% | ND | ND | ND | ND | ND | ND | ND | ND |
| Protein content by BCA | Between 75 and 125 μg/vial (1 dose/vial) | 101 μg/vial | 90 μg/vial | 87 μg/vial | 87 μg/vial | 88 μg/vial | 83 μg/vial | 83 μg/vial | 80 μg/vial | 86 μg/vial |
| Sterility | Absence of growth | Absence of growth | ND | ND | ND | ND | ND | ND | Absence of growth | ND |
| Bacterial endotoxins | <30 IU/dose | 1 IU/dose | ND | ND | ND | ND | ND | ND | ND | ND |
| Particulate contamination: sub-visible particles | ≥10 μm: ≤6000 particles/vial | ≥10 μm: ≤71 particles/vial | ND | ND | ND | ND | ND | ND | ND | ND |
| ≥25 μm: 3 particles/vial | ≥25 μm: 3 particles/vial | |||||||||
a
Degradation bands were a bit more intense as compared to that of reference sample (T0). Presence of degradation bands between 25 and 37 kDa.