- Overview
- Product Highlights
- Interviews
- Resources
- Support and Ordering
Overview
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.
Progress in 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, in a fairly automated manner, is important. It enables identification and isolation of specific immune cells possessing the desired phenotype, at scale. 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.
Product Highlights
CGX10 System Overview
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 the highest 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.
Fully Closed and GMP Ready System
Microfluidic chip-based cell isolation technology
The CGX10 system is equipped with novel microfluidic chip-based cell isolation technology to isolate cells. Unlike mechanical valve based or droplet-based technologies, this Microfluidic chip-based hydrodynamic sorting mechanism handles cells gently maintaining high cell viability and functionality
Full GMP readiness
The CGX10 system aligns with ISO 9001 guidelines in term of instrumentation, the consumables meet ISO 13485 standards and software complies with 21 CFR Part 11 guidelines.
Multiparametric Selection and Expanded Capabilities
When it comes to GMP /clinical grade cell and gene therapy manufacturing workflow, the commonly used magnetic separation technologies isolate cells based on one or two parameters only. In contrast, Flow cytometry-based cell sorting technologies like CGX10 Cell Isolation System are desirable because they offer selection based on multiple parameters (up to ten) simultaneously, and the isolated cells are highly pure.
The system is equipped with four lasers (405 nm, 488 nm, 561 nm, 638 nm) and ten detection channels (two scatter and Hydrodynamic Sorting Waste Top view Sheath Sample Sheath Collection buffer Lasers Waste eight fluorescence) to provide flexible fluorochrome selection for various cell types such as naive T cells, memory T cells (Tscm, Tcm), regulatory T cells (Treg), induced pluripotent stem cells (iPSC). The mixed sorting ratio control feature expands capabilities for cell selection by allowing sorting of multiple target populations at fixed ratios.
Intuitive Software
The CGX10 Cell Isolation System Software (OP Mode) enables compliance with FDA regulation- 21 CFR Part 11 to ensure protection, safety, and security of electronic records in clinical settings. The intuitive software also offers:
- On screen prompts for consumable set-up
- Remote viewing function to view CGX10 screen remotely, in real time.
High Cell Viability
Sony’s novel microfluidics based cell isolation technology isolates cells, minimizing stress to the cells due to absence of mechanical valves and droplet based methods. This technology maintains cell viability and helps maintain function. Additionally, independent temperature control of the sample and sort output reservoirs (from 4°C to 34°C) provides the environment needed for your cells.
Comparison of cell viability obtained when using a conventional cuvette based sorter and the CGX10 Cell Isolation System
Three samples were used to sort target cells using the two types of systems. The viability of sorted cells was calculated and compared side by side. Data indicates that cells isolated using the CGX10 consistently showed higher viability than those sorted using the conventional cuvette based sorter in all three cases. Data generated in collaboration with Mie University
Flexible User Modes
The CGX10 software offers three different modes of operation (roles), ensuring smooth transition through various stages of cell and gene therapy development. The three roles are:
Administrator for configuring the system settings and managing data.
A flexible Process Developer (PD) mode enabling the user to create and optimize the protocol such as gating strategies and visualization parameters.
Operator (OP) mode allowing the user to simply execute previously created protocols. In the Operator mode, all the operations are recorded in the audit trail, so the user can still adjust flow rate and gates while keeping track of all changes. The Operator mode offers a Sort Report or summary at the end and enables compliance with 21 CFR Part 11 guidelines.
Automation at Multiple Levels
