CGX10 Cell Isolation System
The CGX10 Cell Isolation System is a fully closed cell isolation system for GMP-compliant cell production and cell sorting applications. The innovative system design provides superior cell isolation along with ease of operation, with unparalleled flexibility that enables a smooth transition from process development to cell production.
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Progress in the area of cell and gene therapies has accelerated significantly in recent times. Flow cytometry-based cell sorting has been used to sort cells by desired phenotype based on the presence of one or more biomarkers. Sorted cells have been expanded ex vivo and reinfused into patients as cell-based therapies. The ability to use multiple biomarkers is important. It enables identification and isolation of specific immune cells possessing the desired phenotype. Multi-marker-based cell isolation not only delivers a higher purity of isolated cells, but also enables selection to eliminate non-target cells, or therapeutically ineffective cells, for example, over-differentiated T cells.
However, the use of traditional flow cytometers has been limited to research laboratories and preclinical and early phase studies. The complex design of conventional flow cytometers and their usability issues makes them poorly suited to a cell production environment that is GMP compliant. Certain conventional flow cytometers have also been known to shear or cause electrically-induced stress or damage to sorted cells.
The CGX10 Cell Isolation System has been developed with the goal of enabling multi-marker selection to isolate target cells while ensuring high cell viability. The system delivers a user experience that is suited to the GMP compliant, cell production environment, and transcends the complexity and subjectivity of conventional sorter platforms.
The CGX10 Cell Isolation System and related products are intended for use by trained laboratory technicians in research, process development, or manufacturing environments all related to ATMP/regenerative medicine, including cell and gene therapy. The CGX10 instrument and related products are for ex vivo cell separation processing only, and are not intended for therapeutic, diagnostic, or human in vivo applications. Any clinical application of the cells is exclusively within the responsibility of the user of the CGX10 instrument and related products. For the manufacturing and use of cells in humans, regulations must be followed. The CGX10 Cell Isolation System and related products are not sold as medical devices.
The CGX10 Cell Isolation System is classified as a Class 1 laser product.
