TABLE 4.
Time point | 0 h | 4 h | |||||
---|---|---|---|---|---|---|---|
Condition | Vial | Syr. | Syr. + MN | Vial | Syr. | Syr. + MN | |
UV spectroscopy | a/b ratio | 1.46 | 1.46 | 1.45 | 1.38 | 1.41 | 1.44 |
DLS | Z‐average diameter | 3.76 | 3.68 | 3.99 | 3.59 | 3.61 | 4.23 |
In nm (SD) | (0.01) | (0.03) | (0.33) | (0.03) | (0.07) | (0.04) | |
Polydispersity index | 0.191 | 0.203 | 0.191 | 0.188 | 0.177 | 0.182 | |
(SD) | (0.003) | (0.039) | (0.002) | (0.001) | (0.080) | (0.009) | |
HP‐SEC | Monomer content (%) | 99.8 | 98.0 | 98.0 | 99.6 | 99.6 | 99.6 |
Dimer content (%) | 0.2 | 2.0 | 2.0 | 0.4 | 0.4 | 0.4 | |
Molecular weight monomer (kDa) | 157 | 150 | 153 | 155 | 155 | 155 | |
NTA size estimation | Mean in nm (SD) | 429 (233) | 408 (180) | 463 (330) | 386 (182) | 391 (234) | 352 (179) |
MFI | Particles ≥2 μm/mL | 3064 | 2948 | 2948 | 2434 | 2376 | 1773 |
DLS: dynamic light scattering; SD: standard deviation; HP‐SEC: high‐pressure size‐exclusion chromatography; NTA: nanoparticle tracking analysis; MFI: micro‐flow imaging.
UV spectroscopy, HP‐SEC and MFI were measured with adalimumab samples diluted to 1 mg/mL, DLS and NTA in a concentration of 10 mg/mL.