Since COVID-19, the limitless potential of mRNA in the development of innovative therapeutics has been demonstrated, leading to an explosive increase in research on non-viral cell therapy. While LNP technology has been successful in effectively protecting and delivering mRNA into cells, the potential of technologies that do not require delivery media like LNP or Lipofectamine, such as EP (electroporation), has become increasingly apparent for the development of broad-scale cell therapy. However, because mRNA, which is easily destroyed, cannot be mixed with cell solutions, delivery has traditionally been achieved by mixing mRNA with an appropriate EP buffer, which is low in cytotoxicity and RNase-free. While this mixed delivery method is effective for research-oriented intracellular delivery, the cytotoxicity of the EP buffer and the low yield caused by cell damage and loss during the cell washing process make it difficult to apply to commercial cell manufacturing processes. In particular, autologous cells collected from patients have a very limited number of applicable cells, and many of them are difficult to expand and culture. Therefore, it is crucial to avoid the use of EP buffer, a key factor that significantly hinders process yield.

FemtoBiomed has been developing technology for many years with the ultimate goal of developing a delivery platform capable of delivering genetic material without EP buffer. In 2021, the company successfully commercialized its proprietary CellShot Partitioned Flow EP technology, the first delivery platform that does not require EP buffer. This technology loads the cartridge without cell washing or mixing of mRNA and cells. The gene delivery process is then automatically completed within minutes by the CellShot System. Since its development, FemtoBiomed has demonstrated high cell delivery performance and yield in several years of in-house and externally certified experiments. This is attributed to the elimination of cell washing and EP buffer application, significantly reducing cell damage and loss. The development of this partitioned delivery technology has successfully established a strong patent portfolio, differentiating it from competitors and providing technological superiority that easily overcomes the high barriers faced by existing suppliers.

The superiority of this system is demonstrated by differentiated performance data, including high gene transfer performance of patient-derived cells and multiple gene transfer results of more than four types, which are not readily available from existing technology suppliers. (See Primary CD19-CAR-NK Manufacturing Performance, eGFP Expression Performance of Primary PBMCs, and Multiple Gene Transfer Performance.)

CellShot Partitioned Flow EP technology can be applied to more types of cells because there is no mixing of cells and genetic material, and there are almost no restrictions on genetic material, providing a wide delivery domain.