Table 2. VGXI QC testing of purified plasmids NTC8485-O2-gD2 and NTC8485-O2-UgD2tr produced in scaled up cGMP HyperGRO fermentation at VGXI.
| Assay | Result | |
| NTC8485-O2-gD2 | NTC8485-O2-UgD2tr | |
| Nucleic acid concentration by A260, mg/mL | 2.8 | 2.8 |
| Purity by A260/280 | 1.9 | 1.9 |
| Identity by restriction analysis | CTS (conforms to standard) |
CTS (conforms to standard) |
| Structural integrity by percent circular forms analysis by HPLC, (total supercoil) % | 99 | 98 |
| Percent host-cell RNA, % | ≤ 0.2 | ≤ 0.2 |
| Percent host-cell protein, % | ≤ 0.1 | ≤ 0.1 |
| Percent host cell genomic, % | 0.1 | 0.004 |
| Endotoxin, EU/mg | ≤ 0.1 | ≤ 0.1 |
| Osmolality, mOsm/kgH2O | 37 | 27 |
| Visual appearance | Clear, colorless solution free from visible particulates | Clear, colorless solution free from visible particulates |
| pH | 7.7 | 7.7 |
| Plasmid identification - sequencing | No difference from reference sequence | No difference from reference sequence |