Sony CGX10 Cell Isolation System
Cell Isolation You Can Count On
The CGX10 Cell Isolation System is the only 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.
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.
Technology
| Cell Isolation | Closed microfluidics cell isolation technology with patented hydrodynamics control technology |
| Closed/sterile | Single-use, sterile, closed tubing kit and fluid bag connected by sterile welder. Tubing kits are sterilised with EOG (ethylene oxide gas) |
| Automation | Fully automated system setup technology without any beads or non-sample particles. Automatic clog detection and recovery function are provided |
| Ease Of Use | Guided setup and operation for routine and GMP use, including auditable electronic records, comprehensive user privileges and touch screen control |
System Specification
| Dimensions | W: 27.6 in (70 cm) x D: 29.5 in (75 cm) x H: 60.6 in (154 cm) without system status indicator pole (H: 69.3 in (176 cm) with system status indicator pole) |
| Weight | 397 lb (180 kg) |
| LCD Panel | 15.6” touch screen (main), sub monitor can be connected (duplicate mode) |
| Power Supply | 100–240 V, 50/60 Hz, 2 sockets |
| Power Consumption | 1500 W (two independent 750-W circuits) |
| External Interface | Four USB ports and one HDMI port |
| Operating Temperature | 15°C to 25°C |
| Relative humidity | 20% to 60% |
Optics
| Excitation lasers | 488 nm, 638 nm, 405 nm, 561 nm |
| Detectors | V1, V2 450/50 nm, 525/50 nm B1, B2, B3, B4 525/50 nm, 600/60 nm, 695/50 nm, 785/60 nm R1, R2 665/30 nm, 785/60 nm |
| Detectors Parameters | 8 fluorescence + 2 scatter |
Functional Specification
| Sample Input | Sterile Tubing Kit (Standard): 1–25 mL Sterile Tubing Kit (Process Development): depends on user’s selection |
| Sort output devices | Sterile Tubing Kit (Standard): collection bag (max 100 mL) Sterile Tubing Kit (Process Development): depends on user’s selection |
| Temperature control | Active temperature control to manage input sample and sort output reservoirs independently across the range of 4°C to 34°C (using an electric cooling method)* |
| Agitation unit | For sample reservoir and collection bag |
| Event rate | Designed to deliver up to 100,000 eps |
| Sorting speed | Up to 33,000 piezo electric actuations/s on average Designed to achieve purity of about 97% and efficiency of approximately 70% at 15,000 events/s. The yield obtained is based on Poisson’s statistics. Higher threshold events per second can be achieved without affecting purity but with a decrease in yield based on Poisson’s statistics. |
Software
| GUI | Dual Mode full touch screen operation; Process Development Mode and Standard Operation Mode |
| Electronics Records | Features facilitating compliance per 21 CFR Part 11 guidance |
| Output data file structure | Flow Cytometry Standard (FCS) 3.0 or 3.1 |
Compliance
| Operating System | Microsoft® Windows® 10 IOT |
| Safety Standards Compliance | UL, CE, CSA |
- Features & Benefits
-
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.
- Specifications
-
Technology
Cell Isolation Closed microfluidics cell isolation technology with patented hydrodynamics control technology Closed/sterile Single-use, sterile, closed tubing kit and fluid bag connected by sterile welder.
Tubing kits are sterilised with EOG (ethylene oxide gas)Automation Fully automated system setup technology without any beads or non-sample
particles. Automatic clog detection and recovery function are providedEase Of Use Guided setup and operation for routine and GMP use, including auditable
electronic records, comprehensive user privileges and touch screen controlSystem Specification
Dimensions W: 27.6 in (70 cm) x D: 29.5 in (75 cm) x H: 60.6 in (154 cm) without system
status indicator pole (H: 69.3 in (176 cm) with system status indicator pole)Weight 397 lb (180 kg) LCD Panel 15.6” touch screen (main), sub monitor can be connected (duplicate mode) Power Supply 100–240 V, 50/60 Hz, 2 sockets Power Consumption 1500 W (two independent 750-W circuits) External Interface Four USB ports and one HDMI port Operating Temperature 15°C to 25°C Relative humidity 20% to 60% Optics
Excitation lasers 488 nm, 638 nm, 405 nm, 561 nm Detectors V1, V2 450/50 nm, 525/50 nm
B1, B2, B3, B4 525/50 nm, 600/60 nm, 695/50 nm, 785/60 nm
R1, R2 665/30 nm, 785/60 nmDetectors Parameters 8 fluorescence + 2 scatter Functional Specification
Sample Input Sterile Tubing Kit (Standard): 1–25 mL
Sterile Tubing Kit (Process Development): depends on user’s selectionSort output devices Sterile Tubing Kit (Standard): collection bag (max 100 mL)
Sterile Tubing Kit (Process Development): depends on user’s selectionTemperature control Active temperature control to manage input sample and sort output reservoirs
independently across the range of 4°C to 34°C (using an electric cooling
method)*Agitation unit For sample reservoir and collection bag Event rate Designed to deliver up to 100,000 eps Sorting speed Up to 33,000 piezo electric actuations/s on average
Designed to achieve purity of about 97% and efficiency of approximately 70%
at 15,000 events/s. The yield obtained is based on Poisson’s statistics. Higher
threshold events per second can be achieved without affecting purity but with
a decrease in yield based on Poisson’s statistics.Software
GUI Dual Mode full touch screen operation; Process Development Mode and
Standard Operation ModeElectronics Records Features facilitating compliance per 21 CFR Part 11 guidance Output data file structure Flow Cytometry Standard (FCS) 3.0 or 3.1 Compliance
Operating System Microsoft® Windows® 10 IOT Safety Standards Compliance UL, CE, CSA - Documents