Qualification of a flow cytometry-based method for the evaluation of cytotoxicity of GTA002 natural killer cell therapy.

Background: Natural Killer (NK) cell-based therapies represent a ground-breaking opportunity for the treatment of solid tumors and hematological malignancies. NK cell manufacturing under good manufacturing practice (GMP) is complex and requires attentive assessment the product's safety and efficacy through quality control (QC). Release testing includes monitoring of cell expansion, differentiation, purity, phenotype, and cytotoxicity.