Table 3: Specifications and release criteria for manufactured T cell products.

Production stepsSpecifications/release criteria

Peptide stimulation step≥0.5 106 specific T cells among a maximal number of 107 total T cells
Coating of HLA-p on
Chim-AvT beads
RFI ≥ 20 assessed by HLA labeling
Sorting step≥105 rosetted T cells
Amplification step≥108 specific T cells (RC)1

Quality controls

Purity≥90% purity assessed by tetramer labeling (RC)
Activity≥50% TNF producing T cells among tetramer positive ones (RC)
Safety controlsAbsence of microbiological contamination (RC)

RC: release criteria.