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Table 8 Physicochemical properties of PBMCsec 1 and 2 after 6 months of storage at different 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, homogenousReddish brown, uniformly stained, amorphous, not homogenous at the edge of the lyophilisate
Dissolution time40 ± 5 s36.5 ± 0.5 s52.5 ± 10.5 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 of solution and undissolved material was estimated to be in the range of yellow to reddish brown(1)
Clarity and degree of opalescenceClear, equivalent to reference suspension 1 (3 NTU)Clear, equivalent to reference suspension 1 (3 NTU)Between reference suspension 1 (3 NTU) and reference suspension 2 (6 NTU)Parameters could not be evaluated due to large residues of undissolved sample material
Water content4.39 ± 0.12%4.59 ± 0.10%5.46 ± 0.09%7.33 ± 0.43%(1)
pHn.d.n.d.8.7 ± 07.09 ± 0.04 (1)
Osmolalityn.d.n.d.1.4 ± 0 osmol/kgParameter could not be evaluated due to large residues of undissolved sample material
Visible particlesn.d.n.d.0 against white background, 0 against black backgroundVisible particles could not be evaluated due to large residues of undissolved sample material
  1. n.d. not determined
  2. (1)As samples could not be dissolved completely, the validity of these results is compromised