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Table 1 Vaccine release criteria was determined by pathogen load and phenotypic markers

From: Vaccination with dendritic cells loaded with allogeneic brain tumor cells for recurrent malignant brain tumors induces a CD4+IL17+ response

Assay Test method Result (median, range) Specification
Viability (AO/Pl) Fluorescence microscopy 87.0% (61.0%-94.0%) >70%
HLA-DR Flow cytometry 94.5% (69.5%-98.4%) >70%
CD86 Flow cytometry 87.0% (61.5%-94.8%) >70%
Endotoxin LAL <0.7 (<0.4-1.030) <5 EU/mL
Gram stain Standard No organisms No organisms
Sterility (14 days) Bactec No growth No growth
Mycoplasma PTC (28 day culture) Negative Negative