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 Introducing Clinical Grade Optical Cell Sorting
Cytonome’s Gigasort™ technology enables true clinical grade optical cell sorting— sorting that takes place in a closed, sterile, disposable cartridge at sort rates supporting efficient production of human therapeutic cell doses. Cytonome’s advanced and patented microfluidic technology enables optical sorting at up to 14 times faster than existing technology. Gigasort systems support clinical scale, multiple marker cell sorting protocols, including protocols developed using conventional flow cytometry.
Optical Cell Sorting At One Billion Cells Per Hour
The Gigasort technology delivers sorting speeds of up to 1 billion cell sorts per hour with stable operation over lengthy processing periods. The instrument’s ultra high speed is made possible by use of chip based massive parallel arrays of up to 144 concurrently operating microfluidic sorters. Cytonome’s goal is to give cell therapy investigators a tool to produce precision engineered cell transplants at appropriate scale for clinical production.
Closed, Sterile Optical Cell Sorting Is Finally Here
Gigasort systems eliminate the possibility of dose-to-dose or dose-to operator contamination by enclosing all cells and liquids in a closed, sterile, and disposable cartridge. Disposable cartridges also eliminate system downtime required for pre- and post- run cleaning in conventional jet-in-air optical sorters. Each disposable cartridge has a unique barcode to provide full traceability in all manufacturing and clinical production operations. The Gigasort cartridges will be compliant with ISO, CE and cGMP processes for manufacturing and sterilization.
A Breakthrough in Operator Safety
All cells and liquids are confined to a closed, sterile and disposable cartridge without airborne droplets or an aerosol phase. This eliminates the need for vacuum containment systems and facility additions to protect operators against aerosol pathogen exposure. Disposability of the cartridge eliminates risky manual or semi-manual cleaning and servicing procedures and downtime.
Friendly Design for Clinical Users and Facilities
The Gigasort system’s user interface is designed with clinical ease of use in mind. Unattended operation is made possible by the Gigasort system’s real-time monitoring and self-calibration software. A simple cartridge replacement ensures sterility and operator safety while eliminating decontamination requirements common to other cell sorters. The cartridge based design allows clean room production facilities to implement a reliable and convenient standard operating procedure for cell sorting.
Clinical Grade Reliability and Support
Gigasort technology’s use of parallel arrays of microsorters in each cartridge provides extensive redundancy against clogging failures. For example, one clog in a 72 microsorter cartridge decreases cell yield by only 1.4%. Gigasort systems also implement weekly, daily, and runtime self-test operations to assure users that problems are caught and resolved before the start of any cell production run. Cytonome uses each system’s automatic self-test routines to drive Cytonome’s Clinical Grade UptimeSM service program.
Enables Complex Multi-Marker Protocols
Pre-clinical experiments and protocols in cell transplantation are traditionally done with conventional optical cell sorting equipment. The Gigasort technology allows conventional optical cell sorting protocols to be run at clinical scale. 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. None of these cell sorting methods are possible using bulk selection technologies. Existing pre-clinical protocols can transition easily to clinical scale and into production. Cytonome’s mission is to provide Gigasort systems to make these novel protocols available at full clinical scale.
Technology Specifications (Preliminary)
| Sorting Parameters |
2 optical (extinction and side scatter) and 4 to 7 simultaneous fluorescent parameters
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| Sorting Speed |
Up to 1 Billion cells per hour (at 10% hard coincidence)
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| Yield/Recovery |
Ideal yield of viable cells: 90% (actual yields will be source and protocol dependent)
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| Cartridge Capacity |
2.0 Billion cells (optimized for sample concentration of 5x106 per ml)
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