A method that maintains the viability and function of NK cells following cryopreservation, enabling the production, storage, and transportation of therapeutic doses of NK cells to treatment centers.

There is a growing interest in using NK cells as immunotherapies for diseases such as cancer. Making commercially viable NK cell therapies requires large-scale production of NK cells which need to be cryopreserved for storage and transportation to the clinic. However, NK cells do not cryopreserve well; there is a significant loss of cells after cryopreservation, and those that survive are less functional. Poor recovery of NK cells after cryopreservation is a significant barrier to successful commercial development of NK cell therapies.

Pre-treatment of NK cells with the cytokines, interleukin (IL)-15 & 18, under the correct conditions before cryopreservation enables a cryopreserved product of equipotency post thaw without recovery/restimulation in cytokine media.

As cytokines play an essential role in the activation, development, and maturation of NK cells, it was hypothesized that pre-treating NK cells with different cytokines before cryopreservation might help improve NK cell recovery and function. The inventors discovered that NK cells with the pre-treatment of recombinant IL-15 & IL-18 prior to cryopreservation reduced autolysis of the NK cells and pre-treated NK cells maintained their cytotoxicity function post-thaw. In addition to patent rights covering methods of cytokine pre-treatment of NK cells prior to cryopreservation, the technology includes know-how related to cytokine suppliers, concentrations, order of addition and duration of pretreatment.

•    Enables an equipotent cryopreserved NK product.
•    Enables the production, storage, and transportation of therapeutic doses of NK cells to the bedside.
•    Leverages commercially-available sources of GMP-grade IL-15 & IL-18.