Table 1.
Quality attributes of evaluated batches of Transferon.
| Batch | Protein (mg/mL) |
MAB#
(CFU/mL) |
FF&Y&
(CFU/mL) |
Endotoxin (EU/mL) |
|---|---|---|---|---|
| 12A01 | 0.392 | <1 | <1 | <0.05 |
| 12C01 | 0.438 | <1 | <1 | 0.197 |
| 12C03 | 0.432 | <1 | <1 | <0.05 |
| 12C04 | 0.445 | <1 | <1 | <0.05 |
| 12C05 | 0.419 | <1 | <1 | 0.167 |
| 12C06 | 0.394 | <1 | <1 | <0.125 |
| 12C07 | 0.428 | <1 | <1 | <0.125 |
| 12D08 | 0.427 | <1 | <1 | <0.05 |
| 12F09 | 0.427 | 4 | <1 | <0.05 |
| 12G11 | 0.347 | <1 | <1 | <0.05 |
| 12H14 | 0.421 | <1 | <1 | 0.098 |
| 12H15 | 0.406 | <1 | <1 | <0.05 |
| 12K20 | 0.430 | <1 | <1 | <0.125 |
| 12K21 | 0.436 | <1 | <1 | <0.125 |
| 12L22 | 0.432 | <1 | <1 | <0.125 |
| 12L23 | 0.448 | <1 | <1 | <0.125 |
| 13A03 | 0.417 | <1 | <1 | <0.125 |
| 13B07 | 0.423 | <1 | <1 | <0.25 |
| 13C08 | 0.408 | <1 | <1 | <0.25 |
| 12M24 | 0.397 | <1 | <1 | 0.125 |
| 12M25 | 0.422 | <1 | <1 | <0.125 |
| 13A02 | 0.425 | <1 | <1 | <0.125 |
| 13C09 | 0.445 | <1 | <1 | <0.25 |
| 13A04 | 0.398 | <1 | <1 | 1.0 |
| 13C10 | 0.397 | <1 | <1 | <0.25 |
| 13B05 | 0.389 | <1 | <1 | <0.25 |
| 13B06 | 0.389 | <1 | <1 | <0.25 |
#Mesophilic aerobic bacteria; &Filamentous fungus and yeast.