Table 1 Determination of the mean recovery in drug measurement obtained for the two batches of ABP501
Spiked samples (target); µg/ml | Acceptance criteria (µg/ml) | Matrix 1 (M1) | Matrix 2 (M2) | Matrix 3 (M3) | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|
Low | High | µg/ml | Mean (µg/ml) | µg/ml | Mean (µg/ml) | µg/ml | Mean (µg/ml) | µg/ml | % of recovery (%) | |
ADALIMUMAB from ABP501-Batch1 | ||||||||||
1 | 0.8 | 1.2 | 1.3 | 1.3 | 1.2 | 1.3 | 0.9 | 1.1 | 1.20 | 120 |
1.3 | 1.3 | 1.2 | ||||||||
4 | 3.2 | 4.8 | 2.5 | 3.3 | 3.5 | 3.7 | 3.7 | 3.9 | 3.6 | 90 |
4.1 | 3.8 | 4.1 | ||||||||
12 | 9.6 | 14.4 | 13.0 | 13.2 | 8.9 | 10.9 | 10.8 | 12.7 | 12.2 | 102 |
13.3 | 129 | 14.5 | ||||||||
ADALIMUMAB from ABP501-Batch2 | ||||||||||
1 | 0.8 | 1.2 | 1.0 | 1.0 | 0.7 | 0.8 | 1.0 | 1.1 | 0.9 | 93 |
0.9 | 0.9 | 1.1 | ||||||||
4 | 3.2 | 4.8 | 4.2 | 4.4 | 3.7 | 4.1 | 3.6 | 4.3 | 4.2 | 105 |
4.5 | 4.4 | 4.9 | ||||||||
12 | 9.6 | 14.4 | 13.4 | 11.8 | 10.1 | 11.6 | 12.8 | 13.6 | 12.3 | 103 |
10.2 | 13.0 | 14.4 | ||||||||