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 Bringing Complex Multi-Marker Protocols to the Clinic
Researchers normally test a new cell therapy in a murine or animal model prior to human testing. Initial cell selection for animal testing is typically accomplished using conventional optical sorting technology, due to the wide range of cell types that can be isolated using fluorescently-labeled antibodies. Cell selection protocols developed on fluorescent-activated cell sorters are normally transferred to a magnetic bead, solid phase or other clinical-grade separation system when human clinical trials commence, since fluorescent-activated cell sorting technology is neither sterile nor fast enough to generate human clinical doses.
Magnetic bead and bulk separation systems have the advantage of high cell selection speed and disposable, sterile consumables. This allows these technologies to be used in a cGMP cell production setting. Magnetic and bulk separations are only able to select cells with one concurrent marker or physical attribute. Sequential separation steps are required to select cells with multiple markers or attributes using bulk separation technologies. Cell yield and purity decrease for each sequential selection operation when using magnetic separation, and poor yield and purity can occur when trying to select cells with multiple surface markers. Magnetic bead systems are unable to sort cells identified by multiple simultaneous markers (such as the markers needed in certain T-cell protocols), intracellular markers, or cells identified by cell size, optical scatter or threshold sensitive characteristics. The Gigasort technology uses optical sorting technology similar to a conventional FACS and will support all conventional optical flow sorting protocols. This includes the ability to sort cells identified by multiple simultaneous markers, intracellular markers, cell size, optical scatter characteristics or cells with threshold sensitive markers.
The Gigasort technology will support many new and important production processes in cell and gene therapy. These include minimally manipulative selection or depletion protocols (such as autologous progenitor cell selection or tumor purging applications), selection of cells prior to cell expansion or transfection (such as selection of stem cells prior to expansion or ex-vivo gene insertion), and post-processing (or testing) of cells after expansion and selection to ensure homogeneity of the expanded or transfected cell population.
The Gigasort technology supports optical cell selection protocols developed on a conventional droplet-based optical cell sorter. Gigasort technology differs from conventional technology due to its higher speed (2-7 times the speed of a conventional optical cell sorter) and its use of closed, sterile, disposable cGMP cartridges. Unlike bulk separation technologies, Gigasort technology can sort cells identified by complex phenotype. The speed, safety and sterility provided by Gigasort technology will enable the production of new and complex multi-marker protocols in clinical cell therapy. Gigasort users can efficiently transition protocols from pre-clinical experiments developed on conventional optical sorters into human clinical trials. CytonomeST's goal is to enable our collaborators to translate novel cell therapy inventions into clinical trials and commercial production.
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