Table 2.
LAL test precision
| Sample number | Experiment 1 (EU/ml) | Experiment 2 (EU/ml) | Experiment 3 (EU/ml) |
|---|---|---|---|
| 1 |
<0.0050 |
<0.0050 |
<0.0050 |
| 2 |
<0.0050 |
<0.0050 |
<0.0050 |
| 3 |
<0.2500 |
<0.2500 |
<0.2500 |
| 4 |
<0.4000 |
<0.4000 |
<0.4000 |
| 5 |
<0.0500 |
<0.0500 |
<0.0500 |
| 6 |
<0.2500 |
<0.2500 |
<0.2500 |
| 7 |
<0.4000 |
<0.4000 |
<0.4000 |
| 8 |
<0.0500 |
<0.0500 |
<0.0500 |
| 9 |
<0.2500 |
<0.2500 |
<0.2500 |
| 10 |
<0.4000 |
<0.4000 |
<0.4000 |
| 11 |
<0.0500 |
<0.0500 |
<0.0500 |
| 12 |
<0.2500 |
<0.2500 |
<0.2500 |
| 13 |
<0.4000 |
<0.4000 |
<0.4000 |
| 14 |
<0.0050 |
<0.0050 |
<0.0050 |
| 15 |
<0.0050 |
<0.0050 |
<0.0050 |
| 16 |
<0.0050 |
<0.0050 |
0.0627 |
| 17 |
<0.0050 |
<0.0050 |
<0.0050 |
| 18 |
0.0667 |
0.0558 |
<0.0500 |
| 19 |
<0.2500 |
<0.2500 |
<0.2500 |
| 20 |
0.4095 |
<0.4000 |
<0.4000 |
| 21 |
<0.0500 |
<0.0500 |
0.065 |
| 22 |
<0.2500 |
<0.2500 |
<0.2500 |
| 23 | <0.4000 | <0.4000 | <0.4000 |
The LAL test was performed three times under the same operating conditions by the QC manager on our CTPs and supernatants. The test was repeatable. Endotoxin concentrations in all samples (EU/ml) were ≤ 0.5 EU/ml as requested by the Food and Drug Administration. Samples analysed are given in Table 1. Samples: 1 = pyrogen free water (negative control); 2–10 = supernatants with FBS; 11–13 = supernatants with albumin; 14–17 = CTPs; 18–23 = supernatants with HS.