Table 1

Overview of the analytical investigations, number of vials tested at each time point, and the applied test concentrations

Analytical testTest concentrationNumber of samples measured at each time point and storage condition
Visual inspection25 mg/mL33+33+33+3 + 3*+3*
pH25 mg/mL33+33+33+3 + 3*+3*
SEC†0.5 mg/mL and 5.0 mg/mL33+33+33+3 + 3*+3*
MFI25 mg/mL33+33+33+3 + 3*+3*
DLS10 mg/mL33+33+33+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.