pISSN 2234-3806eISSN 2234-3814
Table. 3.
Lot-release specifications of four FDA-approved CAR-T therapies
| Quality attribute | Measurement methods | |||
|---|---|---|---|---|
| Kymriah [60] | Yescarta [61] | Tecartus [62] | Carvykti [63] | |
| Identity | Presence of CAR signal (qPCR) | Linker and CD28 sequences (scFv heavy-chain variable region) | Linker and CD28 sequences (scFv heavy-chain variable region) | Presence of CAR signal |
| Potency | Detection of CAR expression (FACS) | Detection of CAR expression | Detection of CAR expression | Detection of CAR expression |
| Detection of IFN-γ release | Detection of cell viability | Detection of cell viability | ||
| Not disclosed | Not disclosed | Not disclosed | ||
| Purity | % of viable T cells | Endotoxin | Not available | Not disclosed |
| Residual beads | Gentamicin | % of NK cells | ||
| % of viable CD19+ B cells | Not disclosed | Detection of viability | ||
| Safety | Mycoplasma | Mycoplasma | Mycoplasma | Mycoplasma |
| Sterility | Sterility | Sterility | Sterility | |
| Bacterial endotoxin | RCR | Endotoxin | Endotoxin | |
| VSV-G DNA (qPCR) | Not disclosed | RCL | ||
| Not disclosed | ||||
Abbreviations: FDA, Food and Drug Administration; CAR-T, chimeric antigen receptor T; CAR, chimeric antigen receptor; qPCR, quantitative PCR; scFv, single-chain variable fragment; FACS, fluorescence-activated cell sorting; NK, natural killer; VSV-G, vesicular stomatitis virus glycoprotein G; RCR, replication-competent retrovirus; RCL, replication-competent lentivirus.
Ann Lab Med 2024;44:314~323 https://doi.org/10.3343/alm.2023.0382
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