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™ CellT 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.
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.
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.
Specifications:
- Loading Volume: 13 µL/test (4 ch)
- Measuring Volume: 3.4 µL/test (4ch)
- Measuring range: 5 X 10E4 ~ 4 X 10E6 cells/mL (PI); 5 X 10E4 ~ 2 X 10E7 cells/mL (AO/PI)
- Focus: Auto-focusing
- LED: 4W Green LED
- Weight: 7.0 Kg
- Size: 277 X 276 X 270 mm
- Analysis time: < 25 sec/test (4 ch)
- 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
- Extra storage for data backup and recovery: 4TB
