cellenONE Automated Single-Cell Dispensing System

Overview

The cellenONE Automated Single-Cell Dispensing System is a precision-engineered platform developed by cellenion (France) for deterministic, non-invasive single-cell isolation and deposition into multi-well plates. Unlike conventional fluorescence-activated cell sorting (FACS), which relies on hydrodynamic focusing and high-pressure sheath fluid—introducing shear stress and compromising viability—the cellenONE employs piezoelectric acoustic dispensing technology. This contactless, low-shear method generates controlled micro-droplets via ultrasonic excitation of the nozzle, enabling gentle ejection of individual cells without mechanical or electrical perturbation. The system operates under real-time optical monitoring: integrated high-magnification optics continuously image the dispensing tip to verify cell presence, position, and morphology within each droplet prior to deposition. Coupled with automated path mapping and conditional decision logic—where only droplets containing one optically confirmed viable cell are dispensed—the cellenONE achieves true single-cell resolution with ≥95% confidence per well. Designed explicitly for early-stage workflows in monoclonal antibody development and single-cell genomics, it bridges the gap between sample scarcity and assay rigor.

Key Features

• Piezoelectric acoustic dispensing: Eliminates fluidic shear forces, preserving membrane integrity and post-sort viability—critical for sensitive primary cells, iPSCs, and rare immune subsets.
• Real-time optical verification: On-tip imaging at ≥200 nm resolution confirms cell count, size, and morphological integrity within each droplet before deposition.
• No minimum input requirement: Processes as few as 50 cells from ≤5 µL suspension volume—enabling single-cell recovery from limited clinical biopsies or low-yield dissociations.
• Deterministic deposition: Supports 96-, 384-, and 1536-well plate formats with positional accuracy <±25 µm; no stochastic dilution or re-plating required.
• Automated workflow calibration: Machine-learning-assisted nozzle characterization and adaptive path planning ensure consistent performance across operators and cell types.

Sample Compatibility & Compliance

The cellenONE accommodates suspended mammalian cells—including CHO, HEK293, PBMCs, hybridomas, and primary T cells—with diameters ranging from 5–30 µm and concentrations as low as 10² cells/mL. It requires no labeling for basic single-cell dispensing; fluorescent staining is optional and compatible with standard fluorophores (e.g., FITC, PE, APC). The system complies with ISO 13485 design control principles for laboratory instrumentation and supports audit-ready operation under GLP and GMP-aligned environments. All dispensing logs—including timestamped images, droplet metadata, and decision flags—are stored locally with SHA-256 hashing for data integrity. While not a medical device, its output data meets traceability requirements for IND-enabling clone selection studies per ICH Q5D and USP .

Software & Data Management

The cellenONE Control Suite (v3.2+) provides a validated, role-based interface with electronic lab notebook (ELN) integration via RESTful API. Software features include: (i) configurable dispensing protocols with user-defined viability thresholds and morphological filters; (ii) full audit trail compliant with FDA 21 CFR Part 11 (electronic signatures, immutable logs, session timeouts); (iii) export of raw TIFF stacks, CSV-based well maps, and QC metrics (e.g., dispersion coefficient, viability correlation index); and (iv) optional LIMS synchronization for sample tracking across cloning, expansion, and sequencing pipelines. Data backups are encrypted and support NAS or cloud-based repositories meeting HIPAA-compliant storage standards.

Applications

• Monoclonal antibody development: High-fidelity single-cell seeding into 96/384-well plates for clonal outgrowth—replacing labor-intensive limiting dilution with >90% reduction in false negatives and 3× faster clone identification.
• Single-cell RNA/DNA sequencing library prep: Direct deposition of live, unstained cells into lysis-compatible plates, minimizing pre-lysis transcriptional artifacts.
• CRISPR screening hit validation: Isolation of edited clones from heterogeneous pools without FACS-induced selection bias.
• Stem cell line derivation: Viable single-cell cloning of pluripotent lines with preserved differentiation potential.
• Microbiome host-cell interaction assays: Targeted co-culture setup with defined ratios of immune and epithelial cells per well.

FAQ

How does cellenONE differ from traditional FACS in single-cell isolation?

It uses acoustic droplet ejection instead of fluidic sorting—eliminating shear stress, enabling lower input volumes (down to 50 cells), and achieving deterministic rather than probabilistic deposition.
Is cellenONE compatible with downstream NGS library preparation?

Yes—dispensed cells remain viable and unperturbed; plates can be directly processed using commercial single-cell lysis and barcoding kits (e.g., 10x Genomics, Parse Biosciences).
Does the system require fluorescent labeling to operate?

No—optical detection is label-free and based on brightfield/phase contrast; fluorescence channels are optional for gated subpopulation targeting.
What regulatory documentation is provided for GMP-relevant use cases?

A full Design Qualification (DQ) package, Installation/Operational Qualification (IQ/OQ) protocols, and 21 CFR Part 11 compliance statement are included with instrument delivery.
Can cellenONE be integrated into automated liquid handling workflows?

Yes—via standardized USB-C and Ethernet interfaces; supported middleware includes Hamilton VANTAGE, Tecan Fluent, and Opentrons Flex integrations through OEM SDK.