ADAM-CellT Automated Cell Counter for cGMP
ADAM-CellT Automated Cell Counter for cGMP Production
The ADAM-CellT is an automated fluorescence cell counter engineered specifically for cGMP production environments and cell therapy quality control. Built on the same high-performance optical platform as the ADAM-MC2, it adds integrated 21 CFR Part 11 compliance, 4TB extra data storage for backup and recovery, and ADAM calibration beads for rapid instrument diagnosis. The system delivers total cells, viable cells, non-viable cells, and viability percentage in under 25 seconds using PI or AO/PI fluorescence staining with CMOS detection and auto-focusing.
Core Features
21 CFR Part 11 / cGMP Compliance
The ADAM-CellT is designed for regulated cGMP manufacturing environments with full 21 CFR Part 11 compliance built into the system. When 21 CFR Part 11 mode is activated, data cannot be modified by any user. Every action is recorded in a complete audit trail including the date, time, and specific details of the action. Electronic signatures based upon biometrics are designed to ensure they cannot be reused by or assigned to anyone else.
User management separates access into three distinct roles with tiered permissions:
- Admin: Full system access, account creation, firmware updates, date/time settings, electronic records
- Supervisor: Data export (supervisor and user data), electronic records access, saved/deleted document records
- User: Data export (own data only), electronic records access, saved/deleted document records
Data Storage & Calibration
The ADAM-CellT includes 4TB of extra storage for comprehensive data backup and recovery, ensuring long-term traceability of all counting results and audit trails required in cGMP facilities.
ADAM calibration beads allow quick diagnosis when problems occur, ensuring instrument accuracy and reducing downtime. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols are designed to validate instrument performance for regulated environments.
Principle of Viability Measurement
The ADAM-CellT uses two fluorescence staining methods:
- PI (Propidium Iodide) Staining: PI is a membrane-impermeant dye that stains the nuclei of non-viable cells. Viable cells exclude PI. Total cell count is determined by PI-stained nuclei after lysis solution treatment.
- AO/PI (Acridine Orange / Propidium Iodide) Staining: AO stains all nucleated cells (viable and non-viable), while PI stains only non-viable cells. This dual-stain approach provides total cell count and viability in a single measurement.
After staining, the ADAM-CellT automatically takes fluorescent images and processes them through integrated image analysis software. Two types of disposable chips are available: 2-channel and 4-channel configurations.
Cell Therapy Applications
The ADAM-CellT serves as a quality control device to monitor cell numbers and viability throughout the cell therapy manufacturing process:
- Source tissue → Cell isolation → Cell expansion → Cell harvest → Infusion to patients
Compatible cell types include:
- Stem cells
- CAR-T cells
- CAR-NK cells
- Adipose-derived stem cells
- Whole blood cells
- PBMCs (peripheral blood mononuclear cells)
- Aggregated and irregular-shaped cell lines
Accuracy & Reproducibility
Independent validation confirms high correlation and repeatability:
- Flow cytometry correlation (Isolated T cells): R² = 0.9875
- Flow cytometry correlation (Activated T cells): High agreement in viability assessment
- Repeatability across concentrations: Low, medium, and high cell concentrations show consistent CV values under 5% for isolated T cells and under 10% for activated T cells
Technical Specifications
| Specification | Details |
|---|---|
| SKU / Cat. No. | ADAM-CellT |
| Analysis Time | < 25 sec / test (4-channel) < 50 sec / test (2-channel) |
| Loading Volume | 13 µL / test (4-channel) 23 µL / test (2-channel) |
| Measuring Volume | 3.4 µL / test (4-channel) 8.6 µL / test (2-channel) |
| Measurement Range (PI) | 5 × 10⁴ – 4 × 10⁶ cells/mL |
| Measurement Range (AO/PI) | 5 × 10⁴ – 2 × 10⁷ cells/mL |
| Staining Method | Propidium Iodide (PI) or Acridine Orange / PI (AO/PI) |
| Detection Technology | CMOS detection with LED optics |
| Light Source | 4W Green LED |
| Focusing | Auto-focusing |
| Image Analysis | Automated integrated software |
| Chip Type | Disposable microfluidic chip (2-channel or 4-channel) |
| 21 CFR Part 11 | Built-in compliance — user management, audit trail, electronic signature |
| Data Storage | 4TB extra storage for data backup and recovery |
| Calibration | ADAM calibration beads for quick diagnosis and accuracy assurance |
| Validation Support | IQ / OQ / PQ protocols available |
| Dimensions (L × W × H) | 277 × 276 × 270 mm |
| Net Weight | 7.0 kg |
Applications
- cGMP cell therapy manufacturing quality control and process control
- CAR-T cell production — isolation, expansion, harvest, formulation
- Stem cell and adipose-derived stem cell counting and viability
- CAR-NK cell monitoring and potency assessment
- PBMC and whole blood cell analysis
- Regulated environments requiring 21 CFR Part 11 documentation
- Aggregated and irregular-shaped cell line analysis
| Analysis time | < 25 sec/test (4 ch) |
|---|---|
| Loading sample volume | 13µL/test (4 ch) |
| Measuring volume | 3.4 µL/test (4ch) |
| Measuring range | 5 X 10E4 to 4 X 10E6 cells/mL(PI) 5 X 10E4 - 2 X 10E7 cells/mL (AO/PI) |
| Focusing | Auto-focusing |
| Dimensions | (L x W x H) 277 x 276 x 270 mm |
| Laser | 4W Green LED |
| Catalog Number | Product Name | Price | Qty |
|---|---|---|---|
| AD4K-200 | Accuchip 4x Kit (max 400 tests) with Accustain Solution |
$1,034.00
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