ADAM CellT - Automated cell counter for cGMP – Witec AG

Art No | ADAM-CellT
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ADAM-CellT is an automated cell counter that is available in cGMP production environment and complies with 21 CFR part 11.

Description

ADAM-CellT is a new standard of automated fluorescence cell counter. ADAM stands for Advanced Detection and Accurate Measurement. ADAM utilizes sensitive fluorescence dye staining, LED optics and CMOS detection technologies to make the cell analysis more accurate and reliable.

It measures the number of total cells, viable cells, non-viable cells and shows viability results. Combined with a disposable microfluidic chip, the operation is now extremely simple, easy, and cost-effective.

It takes only 25 seconds for ADAM-CellT to present results. ADAM-CellT 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. Every action is recorded in an audit trail including the date, time and specific details of the action.

 

KEY FEATURES & BENEFITS

  • Compliance with 21 CFR part 11
  • Automated image analysis
  • Accurate result
  • Sensitve CMOS detection and precise automatic stage
  • Auto focusing
  • Cell therapy quality control

APPLICATIONS

  • Stem cell
  • CAR-T cell
  • CAR-NK cell
  • Adipose-derived stem cell

 

Principle of Viability Measurement (PI-Staining Method)

After the samples are stained with ˜uorescent dye, propidium iodide, which intercalates DNA to stain the nucleus of target cells, ADAM takes ˜uorescent images automatically. The obtained images are processed by image analysis software integrated inside the system.

Adam CellT - Principle of Viability Measurement

Counting Aggregated and Irregular-Shaped Cells

ADAM provides accurate and reliable results because it counts aggregated and irregular-shaped cells.

  • Accurate count based on cell size and shape
  • Count aggregated cells individually
  • Debris is excluded from results
Adam CellT - counting

Accuracy & Repeatability

Correlation of total cell counting between hemocy-tometer and ADAM using SH-SY5Y cells.

Sample with low, medium and high concentration of cells were counted with ADAM. The repeatability at each level of cell concentration is high.

Adam CellT
Adam CellT

Comparison of Cell Viability

Comparison of cell viability between ADAM, flow cytometry, and manual counting.
SH-SY5Y, Jurkat, HeLa cells were treated with 100, 300μM H2O2 for 3 hours, then analyzed by ADAM, flow cytometry, and manual counting.

Adam CellT - comparison of cell viability

Cell Therapeutic Applications

ADAM can be used as a device for monitoring and QC of the cell numbers and viability in the process of manufacturing cells (CAR-T cells, stem cells, etc.) for Cell Therapy.
In addition, it is possible to use ADAM depending on the cell types (Whole blood cell, PBMCs, etc.) that needs to be monitored during the manufacturing of cell therapy products.

  • Stem cell
  • CAR-T cell
  • CAR-NK cell
  • Adipose-derived stem cell
  • Whole blood cell
  • Aggregated cell
  • PBMCs
Adam CellT - Cell Therapeutic Applications

QC Platform for Producing CAR-T cell

It is easy to monitor all di°erent steps of the puriÿcation, expansion, and formulation of CAR-T cells using the ADAM to ensure precise and reliable results. ADAM can be used for cGMP, process control and quality control of CAR-T cell.

Adam Cell-T

Performance Test from Isolated T Cells

The profiles of T cells which was used for performance evaluation – Flow cytometric analysis of CD3 expression on unsorted (WBC; left panel) or sorted (Isolated T cell; right panel) human peripheral blood lymphocytes.

Adam CellT

Accuracy

Correlation of T cell counting between flow cytometry  and ADAM in Isolated T cells.

Method comparison between ADAM and flow cytometry.

 

Adam CellT

Linearity

Comparison between flow cytometry and ADAM in Isolated T cells.

 

 

 

Adam CellT

Repeatability

The sample that low, medium, and high concentra-tion of isolated T cells were counted with ADAM.

 

 

Low Medium High
MEAN 486,336 1,446,250 2,905,800
CV 4.97 3.05 1.65

Performance Test from Activated T Cells

The phenotypes of activated T cells which was used for performance evaluation – Flow cytometric analysis of CD25 expression on TCR stimulated (Activated T cell; bottom panel) or unstimulated (control T cell; upper panel) T cells.

Viability

Comparison of viability between flow cytometry and ADAM-CellT in Activated T cells.

Repeatability

The sample that low, medium, and high concentration of activated T cells were counted with ADAM.

Adam CellT
Adam CellT
Low Medium High
MEAN 514,470 1,436,925 2,887,715
CV 9.46 6.47 5.05

Data Management

ADAM-CellT complies 21 DFR 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.

Supplier

NanoEntek Inc.
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Specifications

Focus

Auto-focusing

LED

4W Green LED

Loading Volume

23 μL (2ch), 13 μL (4ch)

Measurement range

5 X 10E4 ~ 4 X 10E6 cells/mL

Measuring Volume

8.6 μL (2ch), 3.4 μL (4ch)

Analysis time

< 50 sec / test (2ch), < 25 sec / test (4ch)

Size (L x W x H)

227x276x270mm

Weight

7 kg

Accessories

Art No | ADB-500
Calibration Beads ADAM
140.00 CHF
140.00 CHF
570.00 CHF
570.00 CHF
Art No | ADR-1000
Accustain Solution (1000 tests)

Size: 1 Kit

180.00 CHF
180.00 CHF

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