ICP-MS Results for Elements Related to Glass Leachables Measured from the Freeze-Thawed Samples (Antibody Product and Placebo) and Control Vials without Freeze-Thaw
| Samples | Elements (ppb) | |||
|---|---|---|---|---|
| Si | B | Al | Na | |
| Antibody product control (no freeze-thaw) | 11,954 | 1,085 | 53 | 138,074 |
| Antibody product Arm A (no lamellae occurrence) | 11,589 | 1,140 | 43 | 138,096 |
| Antibody product Arm B (no lamellae occurrence) | 11,949 | 1,334 | 52 | 137,180 |
| Antibody product Arm C (with lamellae occurrence) | 11,688 | 1,123 | 35 | 134,253 |
| Antibody product Arm D (with lamellae occurrence) | 12,124 | 1,302 | 55 | 136,585 |
| Antibody product Arm E (with lamellae occurrence) | 11,082 | 939 | 29 | 128,560 |
| Antibody product Arm F (with lamellae occurrence) | 11,531 | 1,068 | 31 | 134,128 |
| Placebo control (no freeze-thaw) | 4,976 | 1,940 | 7 | 184,367 |
| Placebo Arm G (no lamellae occurrence) | 4,173 | 1,722 | 5 | 173,311 |
| Placebo Arm H (with lamellae occurrence) | 4,094 | 2,003 | 2 | 174,564 |