A Full GMP Process to Select and Amplify Epitope-Specific T Lymphocytes for Adoptive Immunotherapy of Metastatic Melanoma

Table 3

Specifications and release criteria for manufactured T cell products.

Production steps	Specifications/release criteria
Peptide stimulation step	≥0.5 × 10^6 specific T cells among a maximal number of 10^7 total T cells
Coating of HLA-p on; Chim-AvT beads	RFI ≥ 20 assessed by HLA labeling
Sorting step	≥10^5 rosetted T cells
Amplification step	≥10^8 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 controls	Absence of microbiological contamination (RC)

1RC: release criteria.