Revvity Cellaca MX Automated High-Throughput Cell Counter

Overview

The Revvity Cellaca MX Automated High-Throughput Cell Counter is an engineered solution for rapid, standardized, and regulatory-compliant cell quantification in biopharmaceutical development and manufacturing environments. Leveraging high-speed brightfield and fluorescence imaging coupled with deterministic image-based analysis algorithms, the Cellaca MX performs automated viability and concentration measurements using trypan blue exclusion or dual-stain (acridine orange/propidium iodide) protocols. Unlike flow cytometry-based or impedance-based counters, the Cellaca MX captures full-field micrographs of each sample—enabling morphological assessment, debris discrimination, and consistent gating logic across heterogeneous populations such as CHO, HEK293, PBMCs, T cells, stem cells, and whole blood derivatives. Its architecture supports unattended batch processing of up to 24 samples per run, delivering statistically robust results with minimal operator intervention and no manual thresholding.

Key Features

• High-throughput capacity: Processes 24 samples in ≤3 minutes using AO/PI staining; completes trypan blue analysis in 48 seconds for the full 24-well plate.
• Low sample consumption: Requires only 25 µL per test—critical for early-stage cell line development, limited-volume bioprocess samples, or precious primary isolates.
• Wide dynamic detection range: Accurately quantifies cells from 5 µm to 80 µm in diameter, accommodating suspension-adapted lines, aggregated therapeutic cells, and heterogeneous clinical specimens.
• Regulatory-ready design: Fully compliant with 21 CFR Part 11 requirements—including electronic signatures, audit trails, role-based access control, and data integrity safeguards.
• Modular integration capability: Equipped with standard robotic interface ports (RS-232, Ethernet, TTL I/O) for seamless integration into liquid handling platforms, incubator-integrated workflows, or end-to-end automated bioprocess lines.
• Consistent analytical performance: Employs fixed-focus optics, calibrated illumination, and algorithmic normalization to ensure inter-run and inter-operator reproducibility—validated across multiple laboratories under GLP conditions.

Sample Compatibility & Compliance

The Cellaca MX demonstrates validated performance across a broad spectrum of mammalian cell types relevant to modern biotherapeutics: recombinant CHO and HEK293 cultures, peripheral blood mononuclear cells (PBMCs), activated T-cell products, induced pluripotent stem cells (iPSCs), and whole blood preparations. It meets ISO 21732:2020 guidelines for cell counting methodology validation and supports adherence to ICH Q5D, USP , and ASTM E2877-22 standards for cell-based assay characterization. All firmware and software versions undergo formal change control and are documented per GMP Annex 11 expectations. Audit trail records capture user actions, parameter modifications, result exports, and system events with immutable timestamps.

Software & Data Management

The Cellaca MX operates via Revvity’s proprietary Cellaca Software Suite v3.x—a Windows-based application supporting multi-user environments with configurable permission levels. Data files are stored in encrypted SQLite databases with optional export to CSV, PDF, or LIMS-compatible XML formats. The software includes built-in QC dashboards, trending reports for instrument performance monitoring (e.g., CV% over time), and automated pass/fail criteria based on user-defined acceptance limits. Electronic signatures comply with FDA 21 CFR Part 11 Subpart B requirements, including signature justification fields, biometric verification options, and tamper-evident log archiving. Raw image archives (TIFF) are retained alongside processed metrics for full traceability during regulatory inspections.

Applications

• Cell line development: Rapid screening of transfection efficiency, clone selection, and expansion kinetics across hundreds of candidates.
• Upstream bioprocessing: In-process monitoring of bioreactor harvests, seed train expansions, and fed-batch viability profiling.
• Cell therapy manufacturing: Release testing of autologous and allogeneic products—including CAR-T, NK, and dendritic cell preparations—under cGMP conditions.
• Gene therapy vector production: Quantification of producer cell density prior to transduction and post-harvest titer correlation studies.
• QC/QA laboratories: Routine lot release, stability testing, and method transfer activities requiring high inter-laboratory concordance.

FAQ

Does the Cellaca MX require daily calibration or routine maintenance beyond cleaning?
No—optical and fluidic subsystems are factory-calibrated and do not require user-performed recalibration. Daily cleaning protocols are limited to disposable capillary tips and stage wipes; annual preventive maintenance is recommended per Revvity service guidelines.
Can the system be validated for use in regulated GMP environments?
Yes—the Cellaca MX includes IQ/OQ documentation packages, risk assessments (FMEA), and validation templates aligned with ASTM E2500-22 and EU Annex 15 principles.
Is remote monitoring or cloud-based data backup supported?
Local network-based remote desktop access is permitted; however, cloud storage or internet-connected operation is disabled by default to preserve data sovereignty and meet internal IT security policies common in pharma R&D facilities.
How does the Cellaca MX handle clumped or irregularly shaped cells?
Its adaptive segmentation engine applies size-, intensity-, and shape-based filters to resolve aggregates and exclude non-cellular debris without user intervention—validated for >95% accuracy against manual hemocytometer counts across ≥500 test cases.
What consumables are required for routine operation?
Only single-use, pre-sterilized capillary cartridges (Cat. No. CL-MX-24) and compatible AO/PI or trypan blue reagents—no sheath fluid, lasers, or proprietary cuvettes needed.