Control charts for alternative storage stability evaluations with respect to informational value properties are displayed in Fig. 9 and Fig. 10. Informational value measurement results utilized a stability control range taken as the mean value of the unstressed material ±3SD.Fig. 9Mean particle concentration (ECD ≥ 2 μm) results for 14HB-D-001 under accelerated stablity (left) and thaw/freeze (right) conditions using flow imaging. The black line indicates the upper control limit taken as the mean value of unstressed 14HB-D-001 + 3SD and the error bars represent ±1SD for the specific sample. Note that the 40 °C 28 day sample (54,627 ml−1) is indicated with a straight line extending off of the graphFig. 10Mean hydrodynamic diameter results for 14HB-D-001 under accelerated stablity (left) and thaw/freeze (right) conditions using DLS. The black lines indicate the control range taken as the mean value of unstressed 14HB-D-001 ± 3SD and the error bars represent ±1SD for the specific sample. Note that the 40 °C 28 day sample (143 nm) is indicated with a straight line extending off of the graph