NanoEntek ADAM CellT

Product Code: ADAM CellT

Automated Cell Counter for cGMP!

ADAM™ CellT is an automated cell counter that is available in cGMP production environment. It has an easy-to-use built-in tablet and complies with 21 CFR part 11. When 21 CFR part 11 mode is activated, data cannot be modified by any user.

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
  • 4TB extra storage for data backup and recovery

 

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