Maurice iCIEF/CE-SDS Capillary Electrophoresis System by ProteinSimple

Overview

The Maurice system is a fully integrated, dual-mode capillary electrophoresis platform engineered for high-resolution, regulatory-compliant analysis of therapeutic proteins—particularly monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), fusion proteins, and recombinant biologics. It uniquely combines two orthogonal separation techniques in a single instrument: capillary electrophoresis–sodium dodecyl sulfate (CE-SDS) for size-based purity assessment and imaged capillary isoelectric focusing (iCIEF) for charge heterogeneity profiling. Unlike conventional slab-gel or manual capillary systems, Maurice employs full-column imaging detection in iCIEF mode, enabling real-time visualization of the entire pH gradient and focused protein zones without zone compression or mobilization artifacts. In CE-SDS mode, it delivers quantitative UV absorbance detection under both reduced and non-reduced conditions—directly satisfying the method requirements outlined in the United States Pharmacopeia (USP) and Chinese Pharmacopoeia for mAb purity testing. Its architecture eliminates manual capillary handling, thermal instability from high-voltage heating, and variability introduced by fluidic interconnects.

Key Features

• Pre-assembled, disposable capillary cartridges for both CE-SDS and iCIEF—no cutting, polishing, or pressure/flush assembly required.
• Integrated waste reservoir within each cartridge, minimizing cross-contamination and simplifying disposal workflow.
• Low-voltage iCIEF operation (<3 kV) with optimized ampholyte matrix, reducing Joule heating and improving reproducibility of pI migration.
• Automated batch processing: CE-SDS 12-sample runs completed in 5–7 hours; iCIEF single-injection cycle in 6–10 minutes.
• Robust thermal management via Peltier-controlled cartridge holder, maintaining ±0.2 °C stability across multi-hour CE-SDS sequences.
• On-instrument optical imaging system with CCD detector for high-sensitivity, spatially resolved iCIEF band detection (pixel resolution ≤10 µm).

Sample Compatibility & Compliance

Maurice supports native, reduced, and non-reduced protein samples ranging from 10–200 kDa, including intact mAbs, Fab/Fc fragments, ADCs (with DAR characterization), bispecific formats, and glycosylated variants. The system complies with analytical method validation frameworks defined in ICH Q5B (structural characterization), Q5E (comparability), and Q2(R2) (validation of analytical procedures). Its software enforces audit-trail-enabled user authentication, electronic signatures, and immutable raw data storage—meeting FDA 21 CFR Part 11 and EU Annex 11 requirements for regulated environments. All iCIEF methods are compatible with pharmacopeial pI standards (e.g., pI markers traceable to NIST SRM 8461), and CE-SDS assays align with USP specifications for resolution of glycosylated vs. non-glycosylated heavy chains.

Software & Data Management

The Compass Software Suite provides end-to-end control—from method development and instrument calibration to automated peak integration, pI assignment, and comparative overlay analysis. It includes built-in tools for mobility correction, baseline subtraction, and charge variant quantification using area normalization. All processing parameters are saved as metadata within proprietary .cmpx project files, supporting version-controlled method transfer across laboratories. Raw electropherograms and image stacks are stored in vendor-neutral HDF5 format for third-party reprocessing. The software supports GLP/GMP workflows through configurable role-based permissions, change control logs, and retrospective audit trail review—including timestamps for every acquisition, integration, and export event.

Applications

• Quantitative purity assessment of mAbs via CE-SDS under reduced/non-reduced conditions per pharmacopeial mandates.
• Charge variant profiling of biologics using iCIEF for detection of deamidation, oxidation, C-terminal lysine clipping, and sialylation differences.
• Stability-indicating method development for forced degradation studies (e.g., acidic/basic stress, thermal incubation).
• Lot release testing and comparability assessments across manufacturing scales and process changes.
• Characterization of ADC drug–antibody ratio (DAR) distribution and charge-driven payload heterogeneity.
• Support for biosimilar development requiring orthogonal confirmation of higher-order structure–related attributes.

FAQ

Does Maurice require external cooling or chiller units for stable operation?

No—Maurice incorporates an integrated Peltier temperature control system that maintains precise cartridge thermal regulation without auxiliary chillers.
Can CE-SDS and iCIEF methods be validated per ICH guidelines using Maurice?

Yes—the platform’s hardware design, software traceability, and documented performance metrics (e.g., pI RSD <0.1%, CE-SDS area RSD <1%) support full ICH Q2(R2) validation protocols.
Are capillary cartridges compatible across different Maurice instruments?

Yes—all Maurice systems use identical, factory-calibrated cartridges; no instrument-specific cartridge variants exist.
How is data integrity ensured during long-term deployment in GMP labs?

Compass Software enforces 21 CFR Part 11 compliance via electronic signatures, immutable audit trails, and segregated operator/administrator roles with password-protected access levels.
Is method transfer between Maurice systems feasible without re-optimization?

Yes—pre-configured cartridge lot calibration files and standardized voltage/time gradients ensure consistent retention time and pI migration across installations.