Table 3 Compilation of “Viability & Count” Potency Tests for the 31 US FDA-Approved CTPs
From: Analysis of the measurements used as potency tests for the 31 US FDA-approved cell therapy products
Product | Viability & Count | Number (Total = 37) |
|---|---|---|
Hemacord (HSCs) | • “Total nucleated cells (TNC)” • (0.5) “Viability of CD45 + cells” • (0.5) “Viable CD34 + cell count” • “Colony forming unit (CFU)” | 3 |
Clinimmune (HSCs) | • “Total nucleated cells (TNC)” • “Viability of total nucleated cells (TNC)” • (0.5) “Viable CD34 + cell count” | 2.5 |
Ducord (HSCs) | • “Total nucleated cells (TNC)” • “Viable nucleated cells” • (0.5) “Viable CD34 + cells (flow cytometry)” | 2.5 |
Lifesouth (HSCs) | • “Total nucleated cells (TNC)” • “Viable nucleated cells” • (0.5) “Viable CD34 + cells (flow cytometry)” | 2.5 |
Bloodworks (HSCs) | • “Total nucleated cells (TNC)” • “Viable nucleated cells” • (0.5) “Viable CD34 + cells (flow cytometry)” | 2.5 |
Allocord (HSCs) | • “Total nucleated cells (TNC)” • “Viable nucleated cells” • (0.5) “Viable CD34 + cell count” • “Colony forming units (CFU)” | 3.5 |
Clevecord (HSCs) | • “Total nucleated cell number” • “Viability of TNC” • (0.5) “Viable CD34 + cell count” | 2.5 |
MD Anderson (HSCs) | • (0.5) “Total CD34 + count” • Total nucleated cell (TNC) count (per HPC, cord blood) • “Nucleated RBC” • “Viability of nucleated cells” • (0.5) “Viable CD34 + cells” • “Colony forming unit (CFU) assay” | 5 |
Yescarta | • “Cell viability” | 1 |
Tecartus | • “Cell viability” | 1 |
Carvykti | • (0.5) “CAR expression from viable T cells” | 0.5 |
Provenge | • (0.5) “Number of CD54 + cells (flow cytometry)” | 0.5 |
Laviv | • “Cell count” • “Cell viability” | 2 |
MACI | • “Cell number” | 1 |
Zynteglo | • “Colony forming cells (CFC)” | 1 |
Lantidra | • Islet Yield: Dithizone (DTZ) stain and microscopic quantification • Viability: SYTO 13 green/ethidium bromide staining and microscopic evaluation | 2 |
Amtagvi | • “Dose (total viable cells)” | 1 |
Lenmeldy | • “Viability (%)” | 1 |
Ryoncil | • “Cell viability” • “Cell concentration” | 2 |