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