KEY FEATURES & BENEFITS:
– Less than 25 sec to get results
– Cell therapy quality control
– 21 CFR part 11 compliance
– Stem cell, CAR-T cell, CAR-NK cell, Adipose-derived stem cell
– Accurate cell counting and viability
– Automated image analysis
Various Applications Cell Counter for cGMP:
ADAM-CellT complies with 21 CFR part 11. When 21 CFR part 11 mode is activated, data cannot be modified by any user.
Every action is recorded in an audit trail including the date, time and specific details of the action.
ADAM calibration beads allow quick diagnosis when problems occur, which ensures accuracy of the instrument.
– Accurate results for cell counting and viability
– 21 CFR part 11 compliance
– Cell therapy quality control
-Various applications: stem cell/ CAR-T cell/ CAR-NK cell/ Adipose-derived stem cell
Viability Measurement : PI-Staining Method
After the samples are stained with fluorescent dye, propidium iodide, which intercalates DNA to stain the nucleus of target cells,
ADAM-MC2 takes fluorescent images automatically. The obtained images are processed by image analysis software integrated inside the system.
Data Management : 21 CFR Part 11 Compliance
ADAM-CellT complies 21 CFR part 11 which is a regulation about electronic records and signatures for use in cGMP facilities.
When 21 CFR Part 11 mode is activated, data cannot be modified by any user. Every action of users is recorded in an audit trail which includes the date, time, and specific details of the action. Electronic signatures based upon biometrics are designed to ensure that they cannot be reused by, or assigned to, anyone else.
User Management : Access level and rights of users
21 CFR Part 11 consists of limiting system access to authorized individuals.
Users are able to control access within software. It is designated to separate 3 different groups – Admin, Supervisor and User.
All steps of producing CAR-T cell : QC Platform for producing CAR-T cell
It is easy to monitor all different steps of the purification, expansion, and formulation of CAR-T cells using the ADAM to ensure precise and reliable results. It can be used for cGMP, process control and quality control of CAR-T cell.
Data Analysis : Performance Test from Isolated T cells
Figure 1 indicates the profiles of T cells that was used for performance evaluation. Flow cytometric analysis of CD3 expression on unsorted or sorted human peripheral blood lymphocytes. Figure 2 indicates linearity showing comparison between flow cytometry and ADAM in Isolated T cells.
Figure 1 shows accuracy of ADAM Cell-T which is a a correlation of Tcell-counting between flow cytometry and ADAM in Isolated T cells. Figure 2 shows repeatability when the concentration of of isolated T cells is low, medium and high.
Data Analysis : Performance Test from Activated T cells
The below Image indicates the phenotypes of activated T cells which was used for performancce evaluation.- Flow cytometric analysis of CD25 expression on TCR stimulated or unstimulated T cells.
Figure 1 shows the comparison of viability between flow cytometry and ADAM -Cell T in Activated T cells. Figure 2 shows repeatability when the concentration of of isolated T cells is low, medium and high.
Accuracy of system: Validation of ADAM-CellT
ADAM calibration beads allow quick diagnosis when problems occur, which ensures accuracy of the instrument.
Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are designed to validate performance of the instrument.
Technical Specifications
| Product name / Cat. No. | ADAM CellT / ADAM-CellT |
| Loading volume | 23 μL (2ch), 13 μL (4ch) |
| Measuring volume | 8.6 μL/test (2ch), 3.4 μL/test (4ch) |
| Measurement range | 5 X 10E4 ~ 4 X 10E6 cells/mL |
| Focus | Auto-focusing |
| LED | 4W Green LED |
| Weight | 7.0 kg |
| Size (LxWxH) | 277 X 276 X 270 mm |
| Analysis time | < 50 sec / test (2ch)
< 25 sec / test (4ch) |
| Dyes | PI (Propidium Iodide) |
| Connectivity | WIFI (USB Dongle) |
| Cell type | Cell line (clumpy cell, single cell), PMBCs, Adipose Stem cell, Total white blood cell, Primary cells |
