CellSep™ Cell Processing Systems for Cell Therapy Manufacturing

CellSep™ Cell Processing Systems

Amerigo Scientific offers CellSep™ PRO and CellSep™ MAX cell processing systems that operate based on different separation principles, but both of them feature high-precision and multi-weighting systems that can effectively reduce deviations (±2g), and their multiple sensor combinations enable automated process monitoring.

CellSep™ PRO system is a fully closed system that operates based on the principle of gradient centrifugation. By using the core control unit and combining with different protocols and tubing sets, CellSep™ PRO can be used for various cell processing procedures, including peripheral blood mononuclear cell (PBMC) separation, magnetic bead incubation and wash, viral vector transduction, enrichment and cleaning, and filling and completion. Besides standard protocols, customized protocols can also be provided upon request.

CellSep™ MAX system can perform centrifugal concentration on large-volume cell suspensions. It removes the original culture medium and other impurities through the washing buffer, and dispense the product into packages as needed by adding specific preparation solutions, thereby completing the continuous process of concentration, washing, and simple dispense in one step.

Item CellSep™ PRO CellSep™ MAX
Appearance
Separation Principle Axial centrifugal separation Continuous centrifugal separation principle.
Dimension (W*D*H) 282*480*350mm 405*485*380mm
Weight 18 kg 36 kg
Operating System Linux Linux
Separation System Piston Centrifugation Continuous-flow Separation
Max. Rotating Speed/RCF 6000rpm/1149xg 4500rpm/1132×g
Voltage 100-240V~, 50/60Hz
Ambient Temperature 10°C - 30°C
Centrifugal Chamber Volume / 100mL; 300mL
Cell Load / 293T: 6.60E+09; 2.00E+10
T-cell: 3.00E+10; 1.00E+11
Cell Enrichment / 50-1132×g
Concentration Flow Rate 30-200 mL/min
Sample Throughput 0.2-30 L
Cell Washing / 50-1132×g, Washing Efficiency >99%
Cell Formulation / 20 Bags most, 10 mL/bag least

Applications in Cell Processing

CellSep™ PRO and MAX cell processing systems have empowered 20+ IND pipelines, involving CAR-T, CAR-NK, TILs, TCR-T, γδ-T cell therapy types. These two cell processing systems can support customers from IND preparation to clinical Phase III application.

Figure 1. Applications of CellSep™ PRO & CellSep™ MAX

Configurations

CellSep™ processing kits are produced and sterilized (ethylene oxide) in accordance with the ISO 13485 standard. The consumables have been tested and certified by third-party authoritative organizations. The test items include endotoxin, hemolysis, cytotoxicity, etc.

CellSep™ PRO system can perform different cell processes with the processing kit and different specific process protocols.

Figure 2. The configuration of CellSep™ PRO

With the processing kit, the cell fluid continuously flows through the centrifuge cup of CellSep™ MAX system by the peristaltic pump. Under the action of centrifugal force, the cells are trapped in the cup, and the original medium flows into the waste bag, thus enabling the continuous processing of large volumes of cell fluid.

Figure 3. The configuration of CellSep™ MAX

Application Cases of CellSep™ MAX

Kanamycin was used to evaluate the ability of CellSep® MAX to remove impurities. A removal rate test was performed on samples with a predetermined kanamycin concentration. After undergoing washing through various processes 2-6 times, the residual kanamycin concentration in the product was detected. Then, the impurity removal rate was calculated under different cleaning time conditions. The test results showed that using CellSep® MAX could effectively remove the residual substances in the cell culture medium, with an impurity removal rate of 99.9%.

Figure 4. Kanamycin residue

Figure 5. Washing efficiency

Using the CellSep™ MAX cell processing system, 5 liters of cell supernatant can be concentrated in just 25 minutes.

Figure 6. Volume changes during the process of concentrating cell supernatant using CellSep™ MAX

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