GMP Manufacturing of Allogenic iPSC-NK Cells for Immunotherapy

Oct 24, 2025Advances in experimental medicine and biology

Large-Scale Production of Donor-Derived Stem Cell-Based Immune Cells for Cancer Treatment

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Abstract

Human induced pluripotent stem cell (iPSC)-derived natural killer (NK) cells may provide a promising avenue for allogeneic immune cell therapies.

iPSC-derived NK cells are associated with TCR-independent innate immune activity, potentially reducing the risk of graft-versus-host disease (GvHD).
The ability to genetically engineer iPSC-derived NK cells may enhance their therapeutic applications.
A scalable manufacturing process for homogeneous iPSC-derived NK cells could facilitate the development of these therapies.
Current manufacturing processes for iPSC-derived NK cells are not yet validated for regulatory compliance.
There are no approved iPSC-derived NK cell products available on the market at this time.

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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.

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GMP Manufacturing of Allogenic iPSC-NK Cells for Immunotherapy

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