CAR-T QC Items

1.Cell surface marker test

• CART cell analysis
• Immune cell analysis(T、B、NK、NKT、Monocyte、Neutrophils、eosinophils)
• T cell analysis
• T cell exhaustion
• T cell differentiation

2.Replication-Competent Lentiviruses (RCL) (RT-PCR base)

3.Lentivirus vector copy number

4.Cytokine detection

5.Cell viability

6.Other

Lentivirus QC Items

1. Lentivirus tittering

• p24 ELISA (pg/ml)
• Vector copy (copies/ml)
• FACS titration of lentivirus (TU/ml)

2. Virus pH

3. Residual host of protein

4. Residual plasmid DNA

5. Residual Benzonase

6. Residual host of DNA(E1A)

7. Residual host of DNA(E1A)