Table 2. Summary of specifications and test results for clinical grade 78 μg/mL Pfs25-EPA/Alhydrogel vaccine stored at 4°C for 4 years.
| Tests | Method | Specification | Results | |||||
|---|---|---|---|---|---|---|---|---|
| Initial | Year 1 | Year 2 | Year 3 | Year 4 | ||||
| Appearance | Visual | White to slightly yellow suspension with white particulates (consistent with an Alhydrogel formulation) | White to slightly yellow suspension with white particulates (consistent with an Alhydrogel formulation) | White to slightly yellow suspension with white particulates (consistent with an Alhydrogel formulation) | White to slightly yellow suspension with white particulates (consistent with an Alhydrogel formulation) | White to slightly yellow suspension with white particulates (consistent with an Alhydrogel formulation) | White to slightly yellow suspension with white particulates (consistent with an Alhydrogel formulation) | |
| Endotoxin(EU/mL) | USP<85> | < 10 EU/mL | < 0.06 | < 0.12 | < 0.12 | < 0.06 | < 0.06 | |
| Sterility | USP<71> | No growth | No growth | No growth | No growth | No growth | No growth | |
| pH | Measure | 6.0 - 8.5 | 7.05 | 7.36 | 7.65 | 8.06 | 7.95 | |
| Protein Folding | λmax (nm) | Intrinisic Fluorescence | Report results | -- | 330 | 329 | 330 | 330 |
| Intensity (AU) | -- | 0.3054 | 0.2604 | 0.2443 | 0.2137 | |||
| Aluminum Content (μg/mL) | Atomic Absorption | 675 -925 | 781 ± 24.1 | -- | -- | -- | -- | |
| General Safety | USP<88> | Satisfactory^ | Satisfactory | -- | -- | -- | -- | |
| Protein Content (μg/mL) | OPA assay | Report results | 85.9 ± 1.6 | 75.1 ± 1.3 | 81.7 ± 6.4 | 87.7 ± 3.3 | 71.5 ± 2.5 | |
| % Bound to Alhydrogel | OPA assay on supernatants | > 90% Bound | >90% | >90% | >90% | >90% | >90% | |
| DAFIA(μg/mL) | Anti-Pfs25 4B7 mAb recognition | Report results | 88.1 ± 9.3 | 87.9 ± 6.0 | 75.4 ± 1.4 | 87.6 ± 2.8 | 90.7±1.9 | |