Overview of the analytical investigations, number of vials tested at each time point, and the applied test concentrations
| Analytical test | Test concentration | Number of samples measured at each time point and storage condition | |||
| D0 | D2 2–8°C/25°C | D4 2–8°C/25°C | D8 2–8°C/25°C | ||
| Visual inspection | 25 mg/mL | 3 | 3+3 | 3+3 | 3+3 + 3*+3* |
| pH | 25 mg/mL | 3 | 3+3 | 3+3 | 3+3 + 3*+3* |
| SEC† | 0.5 mg/mL and 5.0 mg/mL | 3 | 3+3 | 3+3 | 3+3 + 3*+3* |
| MFI | 25 mg/mL | 3 | 3+3 | 3+3 | 3+3 + 3*+3* |
| DLS | 10 mg/mL | 3 | 3+3 | 3+3 | 3+3 + 3*+3* |
*Indicates additional unopened control vials that have been tested after storage in the same refrigerator and incubator at D8.
†Test concentration of 0.5 mg/mL was used for molecular weight analysis and the test concentration of 5.0 mg/mL was applied for side peak analysis.
D0, day 0 (start); D2, day 2; D4, day 4; D8, day 8; DLS, dynamic light scattering; MFI, micro-flow imaging; SEC, size exclusion chromatography.