Table 2.
Quantitation results of mAb-A DP samples. Results are presented for mAb-A samples collected from different positions in the vial tray along with results from photo and chemically stressed samples.
| Relative Abundance (%) |
|||||
|---|---|---|---|---|---|
| mAb-A Sample | Non-ox | 1-ox | 2-ox | 3-ox | Total Oxidized* |
| Control | 97.5 | 1.9 | 0.6 | ND | 2.5 |
| Back Row | 97.0 | 2.2 | 0.8 | ND | 3.0 |
| Middle Row | 96.8 | 2.2 | 1.0 | ND | 3.2 |
| Front Row | 86.7 | 3.2 | 8.8 | 1.2 | 13.3 |
| UV 4h WL 30h (20% ICH) | 83.1 | 3.1 | 11.7 | 2.0 | 16.9 |
| 100 µM Peracetic Acid | 80.9 | 12.4 | 4.1 | 2.6 | 19.1 |
Total oxidized = Sum of 1-ox, 2 –ox and 3-ox.