Analysis of the measurements used as potency tests for the 31 US FDA-approved cell therapy products

Table 5 Compilation of “Bioassay” Potency Tests for the 31 US FDA-Approved CTPs

Product	Bioassay	Score (Total = 7)
Kymriah	• “Release of IFNγ in response to CD19-expressing target cells” (Novartis slides from Advisory Committee Meeting)	1
Yescarta	• Interferon-γ production by product upon stimulation with CD19 + cells (Papadouli et al., 2020)	1
Abecma	• Interferon-γ production by product upon stimulation with BCMA + cells (EMA Assessment Report)	1
Provenge	• “Increased expression of CD54 on the surface of antigen presenting cells after culture with PAP-GM-CSF (flow cytometry)”	1
Lantidra	• “Glucose Stimulation Index (GSI): ELISA quantification of insulin release by glucose stimulated islets” (slides from Advisory Committee Meeting)	1
Tecelra	• “Cytotoxic activity (cytotoxicity assay with flow cytometry)”	1
Ryoncil	• “Interleukin-2 receptor alpha (IL-2Rα) inhibition bioassay”	1

Quotes are from the FDA website (the product’s Summary Basis for Regulatory Action)
BCMA B cell maturation antigen, ELISA enzyme linked immunosorbent assay, IFNγ interferon gamma, PAP-GM-CSF human prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to human granulocyte–macrophage colony-stimulating factor (GM-CSF), an immune cell activator

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