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. 2016 Jun 15;3:16015. doi: 10.1038/mto.2016.15

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.