ADAM CellT - Automated cell counter for cGMP

Art No | ADAM-CellT

ADAM CellT - Automated cell counter for cGMP

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An Accurate Automated Cell Counter for cGMP

Description

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

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 & 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™-CellT 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 phenotypes of activated T cells which was used for performancce evaluation.- Flow cytometric analysis of CD25 expression on TCR stimulated or unstimulated T cells.

The comparison of viability between flow cytometry and ADAM™ CellT in Activated T cells. Figure 2 shows repeatability when the concentration of of isolated T cells is low, medium and high

Supplier

NanoEntek Inc.
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Specifications

Measuring range	5 x 10⁴ ~ 2 x 10⁷ cells/mL
Optimal range	4 x 10⁵ ~ 1 x 10⁷ cells/mL
Analysis time	Fast mode: 10 sec/test Real Cell size mode: 30 sec/test
Focus	Auto-focusing
Objective lens	4x
Size (L x W x H)	227x276x270mm
Weight	7 kg