Table 7.
Large-scale (200 L) 30% v/v SE batch characterization.
| Target Range | 200-L Batch A | 200-L Batch B | |
|---|---|---|---|
| Date of Manufacture | For information only | 22 May 2018 | 28 November 2018 |
| Particle diameter after 4 recirculating passes on high shear mixer (D50; μm) | ≤7.0 | 4.0 | 4.2 |
| Particle diameter after 3 discrete Microfluidizer passes (Z-ave; nm) | ≤100 | 94 ± 2 | 92 ± 2 |
| Yield % (filtered volume) | For information only | 96% (192 L) | 97% (193 L) |
| Squalene content (% of target) | 80–120 | 99 ± 5 | 114 ± 7 |
| DMPC content (% of target) | 80–120 | 103 ± 5 | 119 ± 7 |
| pH | 5.0–5.5 | 5.2 | 5.2 |
| Processing time (h) | ≤10 | 7 | 7 |