Table 6. Physicochemical Characterization of Five Pilot Lots of Purified DV230-Ficoll.
| attributes | pilot 1 | pilot 2 | pilot 3 | pilot 4 | pilot 5 |
|---|---|---|---|---|---|
| Appearance | clear | clear | clear | clear | clear |
| pH | 7.3 | 7.2 | 7.1 | 7.2 | 7.2 |
| Purity by SEC-HPLCa (%) | >99% | >99% | >99% | 100% | 100% |
| Residual CpG by SEC-HPLC (%) | <1% | <1% | <1% | 0% | 0% |
| Ficoll contentb (mg/mL) | 1.3 | 1.2 | 1.3 | 1.56 | 2.34 |
| DV230 contentb (mg/mL) | 2.9 | 3.2 | 3.0 | 3.8 | 5.7 |
| DV230: Ficoll ratio (M) | 117 | 140 | 117 | 126 | 125 |
| Particle size distributions, mean diameterc (nm) | 49 ± 20 | 53 ± 23 | 47 ± 20 | 47 ± 20 | 48 ± 20 |
| Amount of purified DV230-Ficoll (mg) | 518 | 554 | 468 | 494 | 2100 |
| Endotoxind (EU/mg) | 0.097 | 0.088 | <3 | <1 | <1 |
a
Purity was determined using an SE-HPLC silica-based TSK-Gel G30000SWxl column.
b
Pilot 5 was intentionally delivered at higher DV230 and Ficoll concentrations.
c
Mean particle diameters based on intensity particle size distributions.
d
Endotoxin was measured using a Limulus Amoebocyte Lysate (LAL).