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Specificity data for nimotuzumab binding assay.
| Samples |
% of Binding (Average)
|
Acceptance criteria (%) | ||
|---|---|---|---|---|
| A 431 | NCI-H125 | |||
| Isotype mAb | T1hT | 3,07 | 0,87 | < 5,00 |
| Matrix | Formulation solution | 1,97 | 0,50 | < 5,00 |
| Culture supernatant | 1,37 | 0,83 | < 5,00 | |
| Nimotuzumab | Reference standard | 99,93 | 99,97 | ≥97,00 |
| Culture supernatant | 99,97 | 100 | ≥97,00 | |
| Degraded sample | 92,77 | 67,93 | < 97,00 | |
