NK cells do not require the same level of targeting specificity as other immune cells, such as T cells, to infiltrate the tumor environment, making them an advantageous therapeutic agent. NK cells can recognize non-specific inflammatory signals released in the region of the tumor, extravasate the blood, and infiltrate the tumor microenvironment. Once the NK cells have entered the diseased tissue, the cell contact triggers a cytotoxic response from the NK cells to clear the tumor cells. Because the NK cells have a non-specific tumor response, NK cell therapies are both allogeneic and autologous.
NK cells must be expanded ex vivo to deliver a clinically significantdose, making this the primary challenge in manufacturing GMP-grade NK cell therapies. Upholding the integrity of the complex NK cell phenotype during expansion is imperative to the successful manufacturing of a NK cell therapy that maintains the cells’ innate immune response.
Theragent’s expertise in NK cell biology and immune
response supports the appropriate assay development for validation of the manufacturing process.
The ability of NK cells to extravasate blood into non-specific tumor regions has prompted their use in solid tumor immuno-oncology therapies. There
are currently fourteen NK cell therapies in clinical trials. The NK cell clinical trials include indications for advanced solid tumors, non-small cell lung cancer, glioma, melanoma, and gastric cancer.
At Theragent, we apply the appropriate GMP-grade instruments and protocols to expand NK cells ex vivo under experimentally determined parameters, including culture media and time to enhance their proliferation and cytotoxicity. Following expansion, validating the homing and migrating receptors present on the NK cell surfaces is a necessary manufacturing step that is often incomplete due to lack of validated protocols. Theragent’s expertise in NK cell biology and immune response supports the appropriate assay development for validation of the manufacturing process.
Connect with our team to learn more about our NK cell know-how.