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ADAM™ CellT - Automatisches FLuoreszenz-Zellzählgerät für cGMP

NE-ADAM-CellT

Der ADAM™ CellT ist ein automatisierter, einfach und kostengünstig zu verwendender Fluoreszenz-Zellzähler, der in cGMP-Produktionsumgebungen eingesetzt werden kann. Er arbeitet mit Mikrofluidik-Einwegchips und analysiert PI- oder AO/PI-gefärbte Zellkerne.

Er verfügt über ein benutzerfreundliches integriertes Tablet, welches konform zu Verordnung 21 CFR Teil 11 arbeitet und über eine Benutzer- und Berechtigungsverwaltung verfügt. Wenn der 21 CFR Teil 11-Modus aktiviert ist, können keine Messdaten geändert werden, Benutzeraktionen werden in einem Audit-Trail aufgezeichnet.

Preis auf Anfrage

Produktdetails

Beschreibung

KEY FEATURES & BENEFITS

  • Less than 25s 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 performance evaluation.- Flow cytometric analysis of CD25 expression on TCR stimulated or unstimulated T cells.

​Figure 1은 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.


FOR RESEARCH USE ONLY.

This product is not approved for diagnostic or therapeutic use.


 

References:

 

Single-Cell Analyses Identify Brain Mural Cells Expressing CD19 as Potential Off-Tumor Targets for CAR-T Immunotherapies, Cell, 183 (1), pp. 126-142.e17, October, 01, 2020.

Abstract CD19-directed immunotherapies are clinically effective for treating B cell malignancies but also cause a high incidence of neurotoxicity. A subset of patients treated with chimeric antigen receptor (CAR) T cells or bispecific T cell engager (BiTE) antibodies display severe neurotoxicity, including fatal cerebral edema associated with T cell infiltration into the brain.


Expression of the transcription factor PU.1 induces the generation of microglia-like cells in human cortical organoids, Nature Communications, 13, 430 (2022)


Heterozygous frameshift variants in HNRNPA2B1 cause early-onset oculopharyngeal muscular dystrophy, Nature Communications, 13, 2306 (2022)


A Fully-Human Antibody Specifically Targeting a Membrane-Bound Fragment of CADM1 Potentiates the T Cell-Mediated Death of Human Small-Cell Lung Cancer Cells, International Journal of Molecular Sciences , 23.13 (2022)

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