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Table 7 Physicochemical properties of PBMCsec 1 and 2 after 3 months of storage at various temperatures

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

Test− 20 °C+ 5 °C+ 25 °C+ 40 °C
Appearance of lyophilisateWhite, no color deviations or discolorations, amorphous, homogenousWhite, no color deviations or discolorations, amorphous, homogenousWhite, no color deviations or discolorations, amorphous, homogenousOrange, stained in different shades of orange, several small red spots, amorphous, not homogenous
Dissolution time53.5 ± 1.5 s50 ± 5 s51 ± 8 sCould not be completely dissolved within 15 min
Color of reconstituted solutionEquivalent to reference solution GY5Equivalent to reference solution GY5Equivalent to reference solution GY5Not equivalent to any of the reference solutions GY1–GY7, color was estimated to be in the range of dark orange
Clarity and degree of opalescenceClear, equivalent to reference suspension 1 (3 NTU)Clear, equivalent to reference suspension 1 (3 NTU)Clear, less than reference suspension 1 (3 NTU)Between reference suspension 2 (6 NTU) and reference suspension 4 (30 NTU)
Water content2.65 ± 0.15%3.1 ± 0.1%3.7 ± 0.2%6.15 ± 0.25%(1)
pH8.01 ± 0.518.7 ± 08.85 ± 0.057.95 ± 0.55(1)
Osmolality1.4 ± 0 osmol/kg1.4 ± 0 osmol/kg1.4 ± 0 osmol/kg1.3 ± 0 osmol/kg(1)
Visible particles0 against white background, 0 against black background0 against white background, 0 against black background0 against white background, 0 against black backgroundVisible particles could not be evaluated due to large residues of undissolved sample material
  1. (1)As the samples could not be dissolved completely, the validity of these results is compromised