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Results of biological characterisation
| Parameter | Method | Comparability range (IU/mg) | RGB-10 DP (IU/mg) | Evaluation |
|---|---|---|---|---|
| Biological activity | Cell-based bioassay, UMR-106 cells | 7770.1–11,622 | 9325.0–10,458.6 | Comparable |
| Cell-based bioassay, Saos-2 cells | 8232.7–13,132.2 | 9116.5–12,223.4 | Comparable | |
| Receptor-binding assay | 89.49–130.41 | 104.14–107.16 | Comparable | |
| Immunologic reactivity | ELISA | 9085.6–12,332.4 | 9635.7–11,312.4 | Comparable |
ELISA enzyme-linked immunosorbent assay
