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Table 2 Physicochemical parameters of lyophilized and reconstituted drug substance and placebo

From: Reproducibility of GMP-compliant production of therapeutic stressed peripheral blood mononuclear cell-derived secretomes, a novel class of biological medicinal products

TestPBMCsec 1PBMCsec 2PBMCsec 3placebo
Appearance of lyophilisateWhite, no color deviations or discolorations, amorphous, homogenousWhite, no color deviations or discolorations, amorphous, homogenousWhite, no color deviations or discolorations, amorphous, homogenousWhite, no color deviations or discolorations, amorphous, homogenous
Dissolution time65 s45 s38 s34 s
Color of reconstituted solutionBetween reference solution GY5 and GY6Between reference solution GY5 and GY6Equivalent to reference solution GY5Between reference solution GY5 and GY6
Clarity and degree of opalescenceClear, less than reference suspension 1 (3 NTU)Clear, less than reference suspension 1 (3 NTU)Clear, less than reference suspension 1 (3 NTU)Clear, less than reference suspension 2 (6 NTU)
Water content2.6%2.6%3.0%2.2%
pH8.48.68.68.8
Osmolality1.4 osmol/kg1.4 osmol/kg1.4 osmol/kg1.4 osmol/kg
Visible particles0 against white background, 0 against black background0 against white background, 0 against black background0 against white background, 0 against black background0 against white background, 0 against black background