Figure 5.

Comparative particle size distribution analysis of reconstituted cellular derivative lyophilizate APIs, with and without hydrogen peroxide challenge. (A) The span values revealed a relatively wider particle size distribution for the cell lysate API formulation before the 2% w/w hydrogen peroxide challenge. The results outlined contrary effects of the challenge item on the whole cell API sample group and on the cell lysate API sample group particle size distributions, respectively. (B) The volume distribution parameters showed significant increases in the size of the reconstituted API particles following the hydrogen peroxide challenge. The results were presented as mean recorded values from the experiments where n = 6, assorted to the corresponding standard deviations as the error bars. When comparing results expressed as volume distributions between both types of APIs (i.e., corresponding parameters between the API groups, for the challenged or non-challenged samples, respectively), statistically extremely significant (p < 0.0001) differences were systematically observed, except for the difference in median volume distribution values Dv (50) of the non-challenged API samples (i.e., whole cells vs. cell lysates), which was found to be not statistically significant. Quantitative results of reconstituted API particle size distribution analysis before hydrogen peroxide challenge are presented in Table S1. API, active pharmaceutical ingredients.