ElectroPrep™ System

Overview

The ElectroPrep™ System is an electrophoretically enhanced dialysis instrument engineered for rapid, gentle, and scalable desalting, buffer exchange, and removal of low-molecular-weight contaminants from biomacromolecules. Unlike conventional passive dialysis—which relies solely on diffusion across a semi-permeable membrane—the ElectroPrep™ System applies a controlled direct current (DC) electric field across the dialysis chamber to accelerate ion migration while retaining target macromolecules within the sample compartment. This electrokinetic principle significantly reduces processing time (typically 15–60 minutes versus overnight passive dialysis), improves recovery yields (>95% for most proteins and nucleic acids), and minimizes sample degradation due to prolonged exposure to ambient conditions or proteolytic activity. Designed specifically for clinical laboratory and translational research environments, the system supports reproducible sample preparation workflows compliant with Good Laboratory Practice (GLP) and pre-analytical requirements for downstream applications including mass spectrometry, HPLC, enzymatic assays, and structural biology.

Key Features

• Electrophoretically driven dialysis: Combines membrane-based size exclusion with directional ion migration under low-voltage DC field (0–100 V adjustable, current-limited to ≤5 mA).
• Modular cassette design: Pre-assembled, single-use dialysis cassettes with certified molecular weight cutoff (MWCO) membranes—available in 100 Da, 500 Da, 1 kDa, 3.5 kDa, 10 kDa, 25 kDa, 50 kDa, 100 kDa, and 300 kDa variants.
• Scalable sample volume handling: Accommodates input volumes from 50 µL to 5 mL per run; multiple cassettes can be operated in parallel for batch processing.
• Temperature-controlled operation: Integrated Peltier cooling/heating maintains sample chamber at 4–25 °C ±0.5 °C to preserve thermolabile analytes.
• Automated endpoint detection: Real-time monitoring of conductivity in the external dialysate reservoir enables programmable termination when ion concentration falls below user-defined thresholds.
• CE-marked and ISO 13485-aligned design: Manufactured under quality management systems appropriate for in vitro diagnostic (IVD) ancillary equipment.

Sample Compatibility & Compliance

The ElectroPrep™ System is validated for use with native and denatured proteins (including monoclonal antibodies, enzymes, and recombinant fusion proteins), genomic and plasmid DNA, RNA (including siRNA and mRNA), glycans, lipopolysaccharides, and synthetic polymers. It is compatible with common biological buffers (Tris-HCl, phosphate, HEPES, acetate) and chaotropic agents (urea, guanidine HCl) at concentrations up to 8 M. All wetted components—including cassette housings, membranes, and fluid pathways—are USP Class VI-certified and leachables-tested per ICH Q5A guidelines. The system meets ASTM D512 (chloride determination), ISO 7218 (microbiology), and supports compliance with CLIA, CAP, and College of American Pathologists (CAP) pre-analytical standard SOPs. Traceability logs include timestamped run records, operator ID, cassette lot numbers, and environmental parameters—fully auditable for FDA 21 CFR Part 11–enabled environments when paired with validated LIMS integration.

Software & Data Management

The system operates via embedded firmware with a touchscreen interface supporting multilingual UI (English, Spanish, German, Japanese). Method templates are stored locally and exportable as CSV or PDF reports containing full metadata: applied voltage, elapsed time, temperature profile, conductivity decay curve, and final dialysate conductivity. Optional Ethernet/Wi-Fi connectivity enables secure remote monitoring and integration into enterprise laboratory informatics platforms. Audit trail functionality complies with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), including electronic signatures for method validation and user access control (role-based permissions for operators, supervisors, and administrators).

Applications

• Routine buffer exchange prior to LC-MS/MS analysis of digested peptides.
• Desalting of CRISPR-Cas9 ribonucleoprotein complexes prior to electroporation.
• Removal of free fluorescent dyes after labeling reactions (e.g., Cy3/Cy5 conjugation).
• Preparative purification of exosomes and extracellular vesicles from serum or cell culture supernatants.
• Stabilization of labile protein formulations by rapid replacement of reducing agents (e.g., DTT → TCEP) without dilution.
• Supporting GLP-compliant bioanalytical method development for biopharmaceutical PK/PD studies.

FAQ

What is the maximum recommended sample viscosity for optimal electro-dialysis performance?
Viscosity should not exceed 15 cP; higher viscosities may impede electrophoretic mobility and require dilution or pre-centrifugation.
Can the ElectroPrep™ System be used for endotoxin removal?
Yes—when configured with 10 kDa or lower MWCO cassettes and paired with endotoxin-free reagents, it achieves >99% reduction of endotoxin units (EU) per mg protein, verified by LAL assay.
Is cleaning validation required between runs?
No—single-use cassettes eliminate cross-contamination risk; only external surfaces require routine wipe-down with 70% ethanol.
Does the system support GMP documentation packages?
Yes—comprehensive IQ/OQ/PQ protocols, traceable calibration certificates, and raw data archives are available upon request for regulated manufacturing environments.
How does electro-dialysis compare to gel filtration or spin columns?
Electro-dialysis offers superior scalability, lower sample loss (<5%), no resin binding artifacts, and consistent performance across variable sample loads—unlike column-based methods subject to flow-rate and bed-volume constraints.