CEInfinite Analytical icIEF System
High-Performance Protein Characterization—Simplified.
Designed for precise icIEF analysis, CEInfinite characterizes and monitors the charge heterogeneity of biotherapeutics with accuracy and efficiency.
CEInfinite: icIEF Analytical mode
Ensuring compliance with regulatory guidelines, the CEInfinite delivers efficient and reliable charge heterogeneity analysis with uncompromising quality.
Under the ICH Q6B framework, charge heterogeneity is a critical quality attribute (CQA) for biologics, as charge variants influence protein stability, activity, and immunogenicity. Imaged Capillary Isoelectric Focusing (icIEF) is vital for characterizing and monitoring these variants with precision.
icIEF Technology
Developed by Advanced Electrophoresis Solutions Ltd. (AES), the CEInfinite harnesses state-of-the-art icIEF technology, providing exceptional pI detection consistency and superior separation of complex samples.
With a resolution of 0.03 pI and a sensitivity limit of detection (LOD) of 3 µg/mL for monoclonal antibodies,the CEInfinite ensures robust charge variant analysis. Its whole-column detection at 280 nm absorbance, with detector noise below 0.001 AU, minimizes sample handling and boosts analytical efficiency.
Figure 1: Schematic of icIEF
Why Choose AES?
Unparalleled Reproducibility and Consistency
The CEInfinite excels in reproducibility, as demonstrated with NISTmAb and USP monoclonal antibody standards. It achieves a pI coefficient of variation (CV) below 1% and a CV for peaks ≥10% of ≤4%, with relative standard deviations (%RSD) as low as 0.076% for mAb001. Compared to other icIEF systems with %RSD up to 1.1%, the CEInfinite ensures superior data consistency, essential for quality control and manufacturing release
Figure 2: The icIEF profile for mAb001, mAb002, and mAb003 measured on the CEInfinite.
Table 1: The pI of the main peak for mAb001, mAb002, and mAb003. CEInfinite is based on 6 consecutive runs on 3 different days. The data for other icIEF systems is based on a technical note by USP.
Table 2: The relative area for the acidic, main, and basic peaks of the NISTmAb. CEInfinite is based on 6 consecutive runs. Other icIEF 1 and 2 are based on measurements from 18 different laboratories.
Method Development Capacity
The AESlyte™ carrier ampholytes, paired with advanced capillary coatings (fluorocarbon-based [FC], acrylamide derivative [AD], methylcellulose [MC], and crosslinked silicone [CS]), enhance separation efficiency and reduce protein adsorption. Its versatility in handling diverse proteoforms, such as fusion proteins and antibody-drug conjugates (ADCs), streamlines method optimization for complex biotherapeutics.
Figure 5: Add some typical data with used ampholytes listed in the spectrum.
Software Compliance
The CEInfinite integrates seamlessly with Chromeleon™ and Empower™, ensuring compliance with regulatory standards for data acquisition and processing. This supports operations in strict GMP environments and simplifies audit trails for regulatory submissions.
CEInfinite Chromeleon Driver with Chromeleon CDS Unlocks
- Creation and optimization of processing methods
- Execution of CEInsight sequences
- Customizable data visualization and analysis
- Real-time instrument status monitoring and diagnostics
- Personalized reporting
- Compliance tools for data integrity (audit trails, permission controls, electronic sign-off)
- Visualized rack layout for injection lists
- Auto-Find Exposure for cartridges
- One-button startup for streamlined operation
Figure 6: The AES Chromeleon Driver fully utilizes CM7 on-the-fly pI calibration feature.
AES CEInsight Empower Driver Enhances:
- Integrated pI calibration within Empower, eliminating external software needs
- Full icIEF-Analytical mode functionality
- One-button startup for automated cartridge setup
- Auto-Exposure for optimal cartridge settings
- Live pI spectra with on-the-fly calibration
- Accelerated method development via unified AES icIEF and Empower integration
- Support for all CEInfinite firmware versions
Figure 7: The AES Empower Driver offers simplified pI calibration feature.
Method Transfer and Compatibility
Engineered for seamless method transfer, the CEInfinite employs long-lifetime coated capillaries and lot-to-lot consistent AESlyte™ ampholytes and pI markers, ensuring data reproducibility across platforms. This reduces retraining, revalidation, and redevelopment needs, minimizing costs and production delays while ensuring compatibility with existing icIEF workflows.
Advanced Capabilities
Beyond standard icIEF, the CEInfinite offers fractionation and icIEF-MS coupling, enabling comprehensive charge variant characterization for complex biologics, meeting evolving regulatory demands.
Robust Supply Chain
AES manufactures a comprehensive range of reagents, including carrier ampholytes, cartridges, pI markers, methylcellulose, and system suitability kits. The AESlyte™ carrier ampholytes, offer outstanding resolution and lot-to-lot consistency. AES’s proven track record of meeting industry demand, even during supply shortages, ensures uninterrupted access to critical consumables
Green Chemistry and Environmental Friendliness in CEInfinite icIEF
The CEInfinite embodies green chemistry by adopting sustainable capillary coatings, such as hydrophilic acrylamide derivatives (AD) and methylcellulose (MC), replacing fluorocarbon-based coatings that pose environmental risks.
Optimized AESlyte™ ampholytes minimize reagent use, while icIEF-MS coupling and fractionation reduce solvent consumption and waste compared to traditional LC or IEX methods. Supported by a sustainable supply chain, the CEInfinite delivers high-performance analysis with a reduced environmental footprint, aligning with global green chemistry standards.
Customer Support
AES offers lifetime support for the CEInfinite, with a 24-hour response guarantee and global infrastructure for rapid service and consumable delivery, ensuring operational continuity.
Contact: info@aeslifesciences.com
Instrument Spare Parts
Resources
Explore a curated collection of brochures, technical notes, publications, and posters that complement the CEInfinite icIEF Analytical mode.
These resources offer insights and supporting materials to help you deepen your understanding of charge heterogeneity analysis, regulatory compliance, and icIEF applications—empowering you to achieve reliable, high-quality results.
Get Faster, More Reliable icIEF Results.
Optimize your protein characterization with high-resolution icIEF analysis—faster method development, higher sensitivity, and seamless method transfer. Let’s talk about how CEInfinite can enhance your workflow.
