Table 3.
Characterization of the RH5.1 vaccine clinical batch
| Test | Material | Specification | Result |
|---|---|---|---|
| Sterility test | Vialled product | Pass | Pass |
| Mycoplasma | Bulk harvest lot | Negative | Negative |
| Spiroplasma | Bulk harvest lot | Negative | Negative |
| Viral contamination in vitro: 28-day assay for detection of viral contaminants using three detector cell lines (MRC5, Vero, and C6/36) | Bulk harvest lot | Negative | Negative |
| Viral contamination in vivo: test for presence of inapparent viruses using suckling mice, adult mice, and guinea pigs | Bulk harvest lot | Negative | Negative |
| Abnormal toxicity test | Vialled product | Pass | Pass |
| Endotoxin | Vialled product | ≤1400 EU/mL | 0.482 EU/mL |
| Protein concentration | Vialled product | ≥0.15 mg/mL ≤1.0 mg/mL |
0.174 mg/mL |
| Appearance | Vialled product | Clear, colorless solution essentially free of visible particles | Pass |
| pH | Vialled product | Formulation buffer ± 1.0 pH unit | pH 7.14 |
| Osmolality | Vialled product | 200–600 mOsMol/kg | 319 mOsMol/kg |
| Residual host-cell DNA | Bulk product | ≤10 ng per dose | <180.0 pg/mL |
| Residual host-cell protein by western blot | Bulk product | Report result | Negative |
| Residual C-tag ligand | Bulk product | ≤1 µg/mLa | <2 ng/mL |
| Copia gag western blot | Bulk product | For information only | Negative for copia protein at ~31 kDa |
| Identity by western blot | Vialled product | Positive for RH5.1 | Positive for RH5.1 |
| Purity by SDS-PAGE | Vialled product | RH5.1 bands >90% of total bands detected | >95% |
| HPLC-SEC | Vialled product | For information only | Pass |
Tests are listed with pre-defined specification, the cGMP production material used for testing, and the test result. N-terminal protein sequencing was not done and was not required by the UK regulator (MHRA) for the RH5.1 vaccine to proceed to phase Ia clinical trial
aThis specification was set to equate to <0.67% total protein