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. 2016 Nov 4;7(48):79474–79484. doi: 10.18632/oncotarget.13101

Table 1. Release criteria of final Treg product and result of Treg processing validation.

RELEASE CRITERIA MINIMUM RELEASE CRITERIA (SPECIFICATION) METHOD RESULT FROM VALIDATION
Sterility “no aerobic, anaeorbic and fungal growth” CAP-certified Clinical Microbiology Laboratory “no aerobic,anaeorbic and fungal growth”
Endotoxin < 5 EU/kg EndoSafe PTS Endotoxin System; calculated for an average 70kg person receiving final product 1.28 EU/kg
Mycoplasma <0.8 Lonza MycoAlert Mycoplasma Assay 0.399
Determination of Residual Beads < 100 beads per 3×106 cells counted on hemocytometer after cell permeabilization 91 beads per 3 ×106 cells
% of CD4+ cells >90% flow cytometry in CAP-certified Clinical Hematology Laboratory 99.14%
% of FoxP3+ cells >60% flow cytometry in CAP-certified Clinical Hematology Laboratory 90.64%
% of CD8+ cells <5% flow cytometry in CAP-certified Clinical Hematology Laboratory 0.35%
Viability >75% flow cytometry in CAP-certified Clinical Hematology Laboratory 97.79%