Optimizing the Procedure to Manufacture Clinical-Grade NK Cells for Adoptive Immunotherapy

Natural killer (NK) cells represent promising tools for cancer immunotherapy. We report the optimization of an NK cell activation–expansion process and its validation on clinical-scale. Methods: RPMI-1640, stem growth medium (SCGM), MACS TexMACS were used as culture mediums. Activated expanded (NKAE) obtained by coculturing total peripheral blood mononuclear (PBMC) or CD45RA+ with irradiated K562mbIL15-41BBL K562mbIL21-41BBL. Fold increase, purity, activation status, cytotoxicity transcriptome profile analyzed. Clinical-grade NKAE manufactured in CliniMACS Prodigy. Results: TexMACs achieved highest purity lowest T contamination. Obtaining from was feasible although PBMC yielded higher numbers than cells. The fold expansion using K562mbIL21-41BBL However, no differences found when either source activating line. Transcriptome showed to be different between basal K562mbIL15-41BBL. complied specifications Spanish Regulatory Agency. Conclusions: GMP-grade clinical use can starting aAPC.