“…The OS test is packaged as a complete kit (Lebrun Labs LLC, Anaheim, CA), which includes the OS “Active Agent” (AA) macromolecular reagent formulation (see Lebrun et al, 2022a for a description). As described in prior publications ( Lebrun et al, 2021b , 2022a , 2022b ), samples were initially evaluated using a set of Physiochemical Handling Procedure (PCHP) pretests (see Lebrun et al, 2022a ). Specific physiochemical properties (solubility, buffering capacity, and foaming) of the material to be tested are measured during the pretest step.…”