Table 2. Examples of CAR-T cell release tests.
Parameter | Release testing for CAR-T introduced by retroviral and lentiviral vector | Release testing for CAR-T introduced by transposon/transposase | Release testing for CAR-T introduced by mRNA electroporation |
---|---|---|---|
Safety | • Gram stain/sterility | • Gram stain/sterility | • Gram stain/sterility |
• Mycoplasma | • Mycoplasma | • Mycoplasma | |
• Endotoxin level | • Endotoxin level | • Endotoxin level | |
• Copies of transgene insertion | |||
• RCR/RCL | |||
Purity | • % CD3+ T cells | • % CD3+ T cells | • % CD3+ T cells |
• %CAR-T cells | • %CAR-T cells | ||
• Residual tumor burden | • Residual AAPCs | ||
• Residual beads | |||
Identity | • % CAR T cells |
||
Potency |
In vitro CTL or IFN-γ secretion |
||
Reference | 25 | 22 | 47 |
AAPC, artificial antigen-presenting cells; CAR, chimeric antigen receptor; CTL, cytotoxic T lymphocyte; IFN, interferon; RCL, replication-competent lentivirus; RCR, replication-competent retrovirus.