Table 1.
Summary of potency data at release for 0.25 mM phosphate and 4 mM phosphate in final rPA-AlOH drug product
| Material type | Batch no. | nb | LogED50 | LogED50 SD | ED50 (μg/0.1 ml) |
|---|---|---|---|---|---|
| 0.25 mM phosphate FDPa | 1 | 1 | −0.130 | 0.285 | |
| 2 | 1 | −1.681 | 0.514 | ||
| 3 | 1 | −0.484 | 0.193 | ||
| 4 | 1 | −1.338 | 0.288 | ||
| Weighted mean | 0.21 | ||||
| 4 mM phosphate FDP | 5 | 1 | −2.202 | 0.789 | |
| 6 | 4 | −1.133 | 0.154 | ||
| −1.367 | 0.229 | ||||
| −1.862 | 0.248 | ||||
| −1.273 | 0.159 | ||||
| 7 | 4 | −1.420 | 0.129 | ||
| −1.640 | 1.117 | ||||
| −1.605 | 0.220 | ||||
| −1.451 | 0.203 | ||||
| 8 | 1 | 0.348 | 0.594 | ||
| 9 | 2 | −0.505 | 0.241 | ||
| −1.419 | 0.242 | ||||
| 10 | 1 | −1.175 | 0.235 | ||
| 11 | 1 | −1.397 | 0.265 | ||
| Weighted mean | 0.04 |
a
FDP, final drug product.
b
An n value of 1 means 1 test item comprising a 4-point dilution series with 15 mice/dose and compared to the reference standard. On some occasions, the analysis was repeated up to 4 times to test reproducibility.