Table 7.
Batch analysis of the three Pfs230C1 consistency lots.
| Quality Attributes | Pfs230C1 Lot 1 | Pfs230C1 Lot 2 | Pfs230C1 Lot 3 | ||
|---|---|---|---|---|---|
| Visual appearance | Clear colorless solution | Clear colorless solution | Clear colorless solution | ||
| pH | 7.52 | 6.99 | 7.24 | ||
| SDS PAGE | Single band | Single band | Single band | ||
| Western (anti-his) | Single band | Single band | Single band | ||
| Total Protein (mg/mL) | 0.92 | 1.12 | 1.12 | ||
| SEC | HMW (%) | 0.2 | 0.2 | 0.0 | |
| Monomer (%) | 98.2 | 94.9 | 96.7 | ||
| LMW (%) | 1.6 | 4.9 | 3.3 | ||
| IEX - HPLC | Pre-Peak (%) | 0.2 | 1.1 | 0.6 | |
| Peak 1 (%) | 53.3 | 63.1 | 58.9 | ||
| Peal 2 (%) | 33.3 | 31.4 | 35.2 | ||
| Post-peak (%) | 13.3 | 4.5 | 5.4 | ||
| RP-HPLC | Pre-Peak (%) | 1.8 | 4.4 | 1.6 | |
| Peak 2 (%) | 68.7 | 63.2 | 63.8 | ||
| Peak 1(%) | 25.9 | 28.4 | 29.8 | ||
| Post peak (%) | 3.5 | 4.0 | 4.7 | ||
| Intact mass | Non-reduced | 33510 Da | 33510 Da | 33510 Da | |
| Reduced | 33514 Da | 33514 Da | 33515 Da | ||
| N-terminal sequence | DEYVDEK | DEYVDEK | DEYVDEK | ||
| HCP (ppm) | 155 | 341 | 175 | ||
| Host cell DNA (ppm) | 6.0 | 3.3 | 5.8 | ||
| Residual Ni (ppm) | <0.5 | <0.5 | <0.5 | ||
| Endotoxin (EU/mL) | <0.25 | <0.25 | <0.25 | ||
| Bioburden | TAMC (CFU/mL) | <1 | <1 | <1 | |
| TYMC (CFU/mL) | <1 | <1 | <1 | ||
TAMC: total aerobic microbial count; TYMC: total yeast and mold count.