ProteinSimple MauriceFlex Automated Capillary Electrophoresis System with Fraction Collection
| Brand | ProteinSimple |
|---|---|
| Origin | USA |
| Model | MauriceFlex |
Overview
The ProteinSimple MauriceFlex is an automated capillary electrophoresis platform engineered for high-resolution, quantitative characterization of therapeutic proteins, peptides, viral vectors, and other biopharmaceutical analytes. It implements two orthogonal, pharmacopeial-compliant separation principles: capillary zone electrophoresis under denaturing conditions (CE-SDS) for size-based analysis, and full-column imaging capillary isoelectric focusing (iCIEF) for charge variant profiling. Unlike traditional slab-gel or manual capillary systems, the MauriceFlex integrates hardware automation, thermally stabilized capillary cartridges, and real-time UV/fluorescence detection to deliver reproducible, GMP-aligned data across development, QC, and release testing workflows. Its architecture supports both analytical quantification and preparative fraction collection—enabling direct linkage to orthogonal techniques such as mass spectrometry (MS), peptide mapping, or functional assays without intermediate handling.
Key Features
- Integrated dual-mode operation: CE-SDS and iCIEF on a single platform, each with dedicated, pre-validated cartridge formats
- iCIEF fraction collection module: Enables targeted recovery of individual charge variants (e.g., acidic/basic species, deamidated forms) for downstream structural or functional assessment
- Turbo CE-SDS cartridge: Delivers rapid, high-throughput size analysis (<5 min run time) with enhanced resolution for intact mAbs, ADCs, and subunit fragments
- Plug-and-play capillary cartridges: No manual assembly or buffer filling; thermal stabilization ensures consistent migration velocity and peak shape
- Full-column imaging detection: Real-time monitoring of iCIEF focusing dynamics with digital image capture, eliminating reliance on mobilization steps
- FDA 21 CFR Part 11–compliant software environment with electronic signatures, audit trails, and user access controls
Sample Compatibility & Compliance
The MauriceFlex accommodates a broad range of biologics—including monoclonal antibodies, antibody–drug conjugates (ADCs), fusion proteins, recombinant enzymes, viral vector preparations (AAV, lentivirus), and synthetic peptides—across concentration ranges typical of purified drug substance and product samples. All iCIEF and CE-SDS methods are validated per ICH Q5E and aligned with regulatory expectations outlined in USP , EP 2.2.46, and the Chinese Pharmacopoeia (2020 Edition, Volume IV). The system meets GLP/GMP requirements for method transferability, robustness, and data integrity, with documented IQ/OQ/PQ protocols available. Fraction collection functionality complies with ISO/IEC 17025 traceability standards when coupled with calibrated fraction receivers and sample tracking logs.
Software & Data Management
Maurice Compass for iCE serves as the native control and analysis software, supporting instrument operation, method development, peak integration, and report generation. It includes built-in compliance features: role-based user permissions, immutable audit trails for all parameter changes and result modifications, electronic signatures for approval workflows, and secure data archiving. Raw data files are stored in vendor-neutral formats (e.g., .cdf) and support export to LIMS or enterprise data systems. The software also provides bidirectional communication with Waters Empower® via OpenAccess API, enabling centralized chromatographic and electrophoretic data review within existing QC informatics infrastructure. All processing algorithms—including pI calculation, % area quantitation, and mobility calibration—are fully documented and configurable per internal SOPs.
Applications
- Charge variant profiling of monoclonal antibodies and biosimilars using iCIEF, including identification and isolation of deamidation, oxidation, C-terminal lysine clipping, and sialylation variants
- Reduced and non-reduced CE-SDS analysis for purity assessment, fragment detection, and aggregation quantification in biologics release testing
- Characterization of AAV capsid proteins and empty/full particle ratios via iCIEF and CE-SDS
- Peptide mapping support through fraction collection followed by LC-MS/MS analysis
- Glycoform distribution analysis using lectin-based labeling combined with iCIEF separation
- Stability-indicating method development for forced degradation studies (e.g., pH stress, thermal stress)
- Comparability assessments during process changes, scale-up, or site transfers
- Support for quality-by-design (QbD) initiatives through design-of-experiments (DoE)-driven method optimization
FAQ
Does the MauriceFlex support both reduced and non-reduced CE-SDS analysis?
Yes. The system accepts both reduced and non-reduced CE-SDS cartridges, with optimized separation matrices and detection wavelengths for each application.
Can iCIEF fractions be collected in liquid form suitable for MS injection?
Yes. Collected fractions are dispensed directly into standard autosampler vials or microcentrifuge tubes with minimal dilution and no carryover, preserving compatibility with nanoLC-MS workflows.
Is method transfer between MauriceFlex instruments straightforward?
Yes. Pre-validated cartridge chemistries, standardized temperature control, and identical optical detection geometry ensure high inter-instrument reproducibility; method transfer typically requires only minor retention time adjustment.
How does the system handle low-abundance charge variants?
The full-column imaging detector provides high signal-to-noise ratio across the entire pH gradient, enabling reliable detection and integration of species comprising less than 0.5% of total area.
Is third-party software required for data submission to regulatory agencies?
No. Maurice Compass generates compliant PDF reports with embedded metadata, audit trail summaries, and electronic signatures—fully sufficient for IND, BLA, and MAA submissions.
