Technology Overview
ITRI's GMP-grade iKNOBEADS for human T cells was certified by Taiwan FDA in 2021.
In recent years, cellular immunotherapies like CAR-T have revolutionized the strategy for cancer treatment. Functional magnetic particles have become the most widely used artificial antigen-presenting cells (APCs) for T-cell manufacturing. At present, the commercially available magnetic particles are all spherical. However, the most potent and efficient APCs for T cell activation in vivo are mature dendritic cells with rough membranes with protrusions. Inspired by nature, micrometer-sized magnetic particles with tailorable sizes and knobby shapes were fabricated for the first time, named iKNOBEADS. The uniformity of bead size provides batch-to-batch reproducibility. The non-spherical body creates a larger contact area for cell activation. The magnetic property of beads allows for the ease of separation. These advantages make it ideally suited for the expansion of immune cells.
iKNOBEADS are core-shell structured magnetic particles. The size of beads and shapes are tunable by adjusting the synthetic recipes. The reactive functional groups grafted on the polymeric surface make it easy to modify various stimulatory ligands. We have successfully developed an iKNOBEADS-based 7-day manufacturing process for CD19 CAR-T cells. In a 23-patient study, αβT cells activated by iKNOBEADS exhibit higher expansion efficiency and proportion of TSCM cells than the spherical commercial product. Furthermore, iKNOBEADS have demonstrated enormous potential as artificial APCs for expanding natural killer cells, which opens a new era for allogeneic cell immunotherapy. These results show that iKNOBEADS may offer a more effective feeder-free platform to generate high-quality immune cells for next-generation immunotherapy. GMP-grade iKNOBEADS for human T cells was certified by Taiwan FDA in 2021.
Applications & Benefits
It was demonstrated that these novel magnetic beads can promote greater expansion and better function of T-cells compared to marketed products. A closed cell manufacturing platform with real-time monitoring has also been developed. These technologies have great commercialization potential and can be applied to other cells for immunotherapy.
- A 7-day CAR-T cell manufacturing process has been established, benefiting from the unique morphology of iKNOBEADS, which reduces more than 25% of COGs compared to the current 9–14-day standard process.
- iKNOBEADS offers an efficient feeder-free platform that produces more than 3000-fold expansion of NK cells in 14 days with enhanced anti-tumor potency.
The innovative multi-protrusion design of this technology can effectively reduce the time needed to produce immune cells by 30-45%.
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