Table 3.
Final Variant Set Showing Results of Viral Inactivation and Subvisible Particle Formation During Storage
| Analytical Assay | MS-194 |
MS-200 |
MS-201 |
MS-202 |
||||
|---|---|---|---|---|---|---|---|---|
| Protein A | VI Pool | Protein A | VI Pool | Protein A | VI Pool | Protein A | VI Pool | |
| Oligomer (%) | 0.1 | 2.2 | 0.4 | 0.4 | 0.4 | 0.4 | 0.3 | 0.3 |
| Dimer (%) | 0.8 | 0.8 | 1.9 | 1.0 | 2.3 | 2.0 | 1.7 | 1.2 |
| Total HMW (%) |
0.9 |
3.0 |
2.3 |
1.4 |
2.7 |
2.4 |
2.0 |
1.5 |
| Storage time at 40°C |
||||||||
| 6 wk |
13 wk |
6 wk |
13 wk |
6 wk |
13 wk |
6 wk |
13 wk |
|
| Subvisible particles ≥2 μm | 12,121 | 39,623 | 2043 | 19,523 | 3027 | 19,321 | 1373 | 9881 |