Good manufacturing practice production of an off-the-shelf CD34⁺ progenitor-derived NK cell product with preserved anti-tumor functionality post-infusion in NOD/SCID/IL2Rg^null mice.

ABSTRACT: The adoptive transfer of natural killer (NK) cells represents a promising cancer therapy due to their intrinsic ability to distinguish between malignant and healthy cells in an allogeneic context, enabling off-the-shelf manufacturing possibilities. On demand availability of cryopreserved advanced therapy medicinal products (ATMPs) could promote enrolment in clinical trials and eventually commercialization with repeated dosing possibilities. However, NK cells are considered highly sensitive to cryopreservation-induced defects, including impaired viability, anti-tumor cytotoxicity, and in vivo expansion capacity. Here, we present the GMP-compliant manufacturing of an off-the-shelf NK cell product (RNK001), derived ex vivo from CD34⁺ hematopoietic stem and progenitor cells (HSPCs).

SUBMITTER: Hooijmaijers L 

PROVIDER: S-EPMC12104124 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature