Optimal Combinations of CellGenix^® Reagents Boost Natural Killer Cell Expansion, Viability, and Purity

Cell and gene therapies continue to be the fastest-growing area of therapeutics, with several new therapies available to patients and hundreds more in development. One example of an emerging therapy is natural killer (NK) cell therapy, which utilizes NK cells to target and kill tumor cells more effectively.

Developing such innovative therapies involves overcoming many operational hurdles, particularly during manufacturing (whether scaling up or scaling out). A critical aspect is the optimization of fold expansion, yield, and phenotype. Achieving high fold expansion ensures a sufficient quantity of therapeutic cells, while maximizing yield increases the overall efficiency of the production process. Maintaining the desired phenotype and cytotoxicity is essential to ensure therapeutic efficacy. By focusing on these key factors, researchers can drive the development of more effective and reliable therapies, ultimately improving patient outcomes.

This study aimed to test the ability of CellGenix^® GMP Stem Cell Growth Medium (SCGM) and CellGenix^® recombinant human cytokines to generate functional NK cells with the highest yield while maintaining cytotoxic activity. CellGenix^® GMP SCGM is a xeno-free medium that can be used for various NK cell applications when supplemented with human serum and CellGenix^® IL-2, IL-12, IL-18, and IL-21. CellGenix^® GMP SCGM is produced following applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and ISO 20399:2022.

This application note outlines an NK cell therapy production process, covering expansion and functional characterization, including cytotoxicity, phenotype, and viability. A 24-well scale-down model was used to compare CellGenix^® GMP SCGM with other commercially available NK cell media.