Table 3.
Deamidation and oxidation modifications of HS628 and originator tocilizumab.
| Modification site | Modification type | Mass signal intensity (%) | |||||
|---|---|---|---|---|---|---|---|
| HS628 (20130901) |
HS628 (20130902) |
HS628 (20130903) |
HS628 (20130904) |
Originator tocilizumab (B2014B10) |
|||
| Heavy chain | N(77)QFSLR | Deamidation | 5.2 | 4.2 | 3.8 | 3.9 | 3.7 |
| DTLM(254)ISR | Oxidation | 2.5 | 1.5 | 1.9 | 1.8 | 3.3 | |
| FNWYVDGVEVH N(288)AK |
Deamidation | 22.6 | 21.8 | 20.6 | 20.5 | 21.4 | |
| VVSVLTVLHQDWL N(317)GK |
Deamidation | 99.8 | 99.7 | 99.8 | 99.6 | 99.7 | |
| GFYPSDIAVEWES N(386)GQPENNYK |
Deamidation | 75.6 | 82.6 | 74.9 | 76.6 | 75.5 | |
| WQQGNVFSCSVMHE ALHN(436)HYTQK |
Deamidation | 6.7 | 7.7 | 6.7 | 6.2 | 6.8 | |
|
| |||||||
| Light chain | ASQDISSYLN(34)WYQQKPGK | Deamidation | 1.9 | 2.5 | 1.5 | 1.9 | 1.6 |
| SGTASVVCLL N(137)NFYPR |
Deamidation | 44.4 | 37.8 | 34.2 | 35.4 | 41.5 | |
| SGTASVVCLLN N(138)FYPR |
Deamidation | 5.9 | 5.5 | 4.7 | 4.9 | 5.8 | |