Flow imaging (FI) and dynamic light scattering (DLS) were performed according to the optimized methods described in publication 3 of this series . To establish homogeneity and assign informational values, six vials (two obtained from each rack numbered 1, 50, and 90) from each of lot 14HB-D-001, 14HB-D-002 and 14HB-D-003 were analyzed by FI. Three vials from each lot 14HB-D-001, 14HB-D-002 and 14HB-D-003 were used for homogeneity assessment by DLS. A total of twelve vials were evaluated from the 14HB-D-001 lot that had undergone 1 or 5 thaw/freeze cycles at either −80 °C or at −20 °C. The same number of vials containing PS 8670, stressed in an identical fashion, was also used for comparison. A total of 22 vials from the 14HB-D-001 lot were used for a stability study. This sample set contained the following: four zero time point vials, six vials stored at 4 °C for 7 days or 28 days, six vials stored at room temperature for 7 days or 28 days, and six vials stored at 40 °C for 7 days or 28 days. The formulation buffer (described in ESM) alone was also stressed under the same conditions and assessed for subvisible particle concentration. Method performance was evaluated on the day of analysis by injection of the method-specific instrument quality control standard (IQ) and PS 8670 as the system suitability standard. Data collection and analysis for each method was performed as described previously .