GMP Manufacturing of Allogenic iPSC-NK Cells for Immunotherapy.

Human induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells are the most suitable immune cell therapy types for allogeneic application, due to the TCR-independent innate immune activity of NKs devoid of GvHD side effects. In addition, the amenability of genetic engineering and the potential of scalable manufacturing of homogenic iNK from an established bank of iPSC clones make it an excellent starting material for cell therapies. However, as there is no approved iNK therapeutic product on the market yet, the extent of robustness and regulatory compliance of good manufacturing practice (GMP) is not established and proven, nor is it straightforward. We will review the current development and validation status of iPSC-NK manufacturing processes, along with quality controls, based on literature information and our own experience, towards the goal of manufacturing large-scale iNK products for regulatory submission and future commercialization.