ExoDisc™ EV Isolation System

Overview

The ExoDisc™ EV Isolation System is a benchtop centrifugal microfluidic platform engineered for rapid, label-free, and high-fidelity isolation of intact extracellular vesicles (EVs) from complex biological fluids—including cell culture supernatant (CCS), human urine, plasma, serum, and conditioned media. Unlike ultracentrifugation or polymer-based precipitation methods, the ExoDisc™ leverages size-exclusion and immiscible-phase filtration within a disposable, rotationally actuated disc cartridge to separate EVs (30–200 nm) from soluble proteins, lipoproteins, and aggregates—preserving native morphology, surface epitopes, and cargo integrity. Designed for reproducible pre-analytical standardization, it addresses critical bottlenecks in EV biomarker discovery, therapeutic development, and clinical assay validation under GLP-aligned workflows.

Key Features

• Label-free isolation preserving native EV structure and surface marker expression (e.g., CD9, CD63, CD81)
• Centrifugal microfluidic architecture enabling consistent shear-controlled separation without chemical reagents or antibodies
• Compact footprint (≤25 cm × 25 cm) suitable for biosafety cabinets and shared core facility environments
• Single-use, sterile ExoDisc™ cartridges—pre-validated for low background protein carryover (<5 µg/mL albumin in eluate)
• Minimal hands-on time: <2 minutes for loading; remaining steps fully automated via integrated rotor control
• Consistent recovery efficiency across sample types: ≥75% particle yield (by NTA) from 1 mL CCS; ≥60% from 1 mL urine (pH-adjusted)
• No pre-clearing, ultrafiltration, or PEG precipitation required—eliminating aggregation artifacts and procedural variability

Sample Compatibility & Compliance

The ExoDisc™ supports validated processing of human and murine-derived samples, including: clarified cell culture supernatants (adherent and suspension lines), EDTA-plasma, citrate-plasma, urine (centrifuged at 2,000 × g, 10 min), and saliva (debris-filtered). Each cartridge undergoes endotoxin testing (<0.5 EU/mL) and biocompatibility assessment per ISO 10993-5. The system complies with ISO/IEC 17025 documentation requirements for method validation and supports audit-ready record retention when paired with optional LIMS integration. While not FDA-cleared as an IVD device, its performance aligns with MISEV2018 minimal experimental criteria for EV isolation and is routinely cited in publications meeting ISEV reporting standards.

Software & Data Management

Operation is controlled via a dedicated Windows-based interface supporting protocol selection (CCS, urine, plasma), rotor speed ramping profiles (500–3,000 rpm), and real-time status monitoring (rotation speed, elapsed time, error codes). All run logs—including date/time stamp, operator ID, cartridge lot number, and selected parameters—are exported as CSV or PDF for traceability. Audit trail functionality meets ALCOA+ principles and is compatible with 21 CFR Part 11-compliant electronic signature modules when deployed in regulated QC laboratories. No cloud connectivity or remote access is embedded—ensuring data sovereignty and compliance with institutional IT security policies.

Applications

• Pre-analytical enrichment of EVs for downstream characterization: nanoparticle tracking analysis (NTA), cryo-EM, transmission electron microscopy (TEM), and scanning electron microscopy (SEM)
• Downstream molecular profiling: RNA-seq, small RNA sequencing, digital PCR (dPCR) for miRNA quantification, and proteomic analysis via LC-MS/MS
• Functional assays: EV uptake studies (fluorescent labeling post-isolation), in vitro co-culture modeling, and immunophenotyping by flow cytometry (using bead-assisted capture)
• Translational research: Biomarker validation cohorts (plasma/urine), longitudinal monitoring in oncology and neurodegenerative disease studies
• Manufacturing support: Process consistency evaluation during EV-based therapeutic production (e.g., MSC-EV batches)

FAQ

What is the recommended storage condition for processed EV pellets?
EVs isolated using ExoDisc™ should be resuspended in PBS (Ca²⁺/Mg²⁺-free) or Tris-buffered saline and stored at –80 °C in single-use aliquots. Avoid repeated freeze-thaw cycles.
Can ExoDisc™ isolate exosomes specifically, or does it capture all EV subtypes?
The ExoDisc™ isolates the heterogeneous EV population sedimenting within the 30–200 nm hydrodynamic diameter range—encompassing small exosomes, ectosomes, and non-membranous nanoparticles. Subtype resolution requires orthogonal techniques (e.g., immunoaffinity capture post-isolation).
Is cartridge lot-to-lot performance validated?
Yes. Each ExoDisc™ cartridge batch undergoes functional testing using reference CCS and NIST-traceable polystyrene nanobeads (100 nm) to verify cutoff fidelity and recovery CV ≤8.5%. Certificates of Analysis accompany every shipment.
Does the system require calibration or routine maintenance?
No scheduled calibration is required. The rotor assembly is factory-balanced and sealed; only routine cleaning of the chamber surface with 70% ethanol is recommended between runs.
How does ExoDisc™ compare to ultracentrifugation in terms of co-isolation of lipoproteins?
Independent comparative studies show ExoDisc™ reduces ApoB-100 contamination by >90% relative to UC (as measured by ELISA), significantly improving specificity for downstream proteomic analysis.