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. 2021 Feb 2;87(8):3162–3176. doi: 10.1111/bcp.14729

TABLE 4.

Characterization of adalimumab after passage through a glass vial, a syringe, or a syringe with a hollow microneedle (Syr. + MN), at 0 hours and after storage at 4°C for 4 hours. Representative data of 2 independent experiments

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.