Post-thaw viability of at least 80 percent, usually higher; cell count at or above the label claim; purity by flow cytometry for sorted subsets; mycoplasma negative; sterility negative for bacteria, yeast and fungi; endotoxin below 5 EU/mL where specified; donor serology negative for HIV, HBV, HCV and syphilis. For irradiated PBMC there is an additional functional check: the cells must fail to proliferate while remaining viable, with a residual rate under 10 percent after 14 days of culture.
