Capillary Gel Electrophoresis

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Capillary Gel Electrophoresis

Method Introduction

Capillary gel electrophoresis (cGE) is a high-resolution and automated variation of the SDS-PAGE technique. SDS-PAGE (Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis) is a technique used to separate proteins based on their molecular weight. It works by denaturing proteins with SDS, which coats them with a negative charge and unfolds them, allowing them to be separated in a gel under an electric field. The separation is primarily based on size, with smaller proteins migrating faster through the gel. In general, electrophoresis is a separation technique based on the migration of charged molecules in response to an electric field toward the electrode of opposite charge. It is performed mainly in polyacrylamide gels. In cGE, the gel is located inside a capillary through which the sample components must migrate. The larger the molecular weight, the longer the migration time. A detection system, mainly UV or fluorescence detection, detects and quantifies the migrating species. Molecular weight is determined in reference to a standard.

Applications

Capillary gel electrophoresis (cGE) allows for the qualitative and quantitative analysis of the molecular weight of protein aggregates and fragments.

Compared to conventional SDS-PAGE, cGE allows for much higher resolution, faster sample analysis, and a lower detection limit. Moreover, automation makes cGE attractive during formulation development, stability studies, and forced degradation studies.

If required, we can update SDS-PAGE to cGE for our customers.

Quality and Biosafety Level

We provide all our analytical services with the highest quality standards. Experienced scientists carry out each project, and a scientific reviewer comprehensively checks every report or data presentation.

We offer this technology with the following quality and biosafety levels:

R&D level

We offer this method under R&D. Our GRP system assures the highest-quality research standards.

Up to biosafety level 1

This method can be applied to proteins, nucleic acids, and most viral vectors, including AAVs and more.

Capillary Gel Electrophoresis (cGE) Frequently Asked Questions (FAQs)

  • Capillary gel electrophoresis (cGE) is a high-resolution, automated technique used for separating biomolecules based on their size. It is a modern, capillary-based variation of SDS-PAGE, allowing for faster, more sensitive, and more reproducible analysis of proteins and protein fragments.

  • Unlike SDS-PAGE, which uses slab gels, cGE is performed inside a narrow capillary filled with polyacrylamide gel. cGE offers superior resolution, faster analysis, and greater automation, making it an ideal tool for stability studies, forced degradation analysis, and formulation development.

  • cGE is used to qualitatively and quantitatively assess protein fragments and aggregates. It provides molecular weight determination by comparing migration times to known standards, supporting detailed protein characterization throughout the development cycle.

  • Yes. Coriolis can adapt or replace SDS-PAGE methods with cGE to improve sensitivity, reproducibility, and throughput. This transition is particularly valuable when higher resolution or automation is needed in regulated environments.

  • cGE typically employs UV or fluorescence detection systems to track protein migration through the capillary. These allow accurate quantification of separated species and support low detection limits to detect trace fragments and aggregates in sensitive samples.

  • Coriolis performs cGE under research-grade (R&D) conditions that adhere to Good Research Practice (GRP). While not GMP by default, cGE results are generated with rigorous scientific oversight and can support early development decision-making.

  • cGE can be applied to proteins, nucleic acids, and most viral vectors, including adeno-associated viruses (AAVs), under biosafety level 1 (BSL-1) conditions.

  • cGE is well-suited for formulation development, stability testing, and forced degradation studies. It supports comparability assessments and early-phase screening of therapeutic candidates when fast and precise separation is required.

  • As part of Coriolis’ aggregate analytics platform, cGE complements other techniques, such as HP-SEC and SV-AUC, by offering a gel-based approach for detecting and sizing aggregates with high resolution and reproducibility.

  • Coriolis combines deep scientific knowledge, advanced instrumentation, and flexible method development to tailor cGE services to your specific molecule and phase of development. Each project is executed by experienced analysts and reviewed by expert scientists.

Analytical Method Development, Qualification and Validation

For common sample types, we can often apply standardized methods with little setup effort. However, when needed, our experienced analytical experts create or optimize custom methods tailored to your active pharmaceutical ingredient, product type and development phase.

Method Development

Our method development approach tailors sample preparation, method settings and data analysis to the needs of your project and sample.

We include representative samples and, where available, suitable reference standards and stressed/degraded materials, allowing our analytical scientists to design a highly suitable, stability-indicating, robust and repeatable method. Upon request, we will compile a detailed description of the method for your records.

Method Qualification

Method qualification is the initial assessment of an analytical procedure’s performance to show its suitability for its intended purpose.

During method qualification, our analytical scientists perform documented testing demonstrating that the analytical procedure meets criteria in several categories. Criteria may include factors such as repeatability, specificity and robustness. We compile a qualification plan and report, including all relevant data.

Method Validation

Under GMP conditions, method validation confirms that an analytical procedure’s performance suits its intended purpose. Depending on the method’s scope, a broad range of method characteristics, such as specificity, accuracy, precision, limit of detection/limit of quantification (LOD/LOQ), linearity and range, is considered.

During method validation, our analytical scientists perform documented testing demonstrating that the analytical procedure consistently produces a result that meets the predetermined acceptance criteria. We compile a validation plan and report that includes all relevant data.

Depending on the development phase, a fit-for-purpose validation approach can be offered, adjusting the validation required efforts in a phase-appropriate way to meet the method’s needs.

Method Verification

Compendial method verification confirms that a compendial method (e.g., from Ph. Eur. or USP) is suitable and reliable for its intended purpose under the specific conditions of the laboratory.

Unlike full method validation, compendial method verification is often considered a partial validation since the method has already undergone extensive testing and validation during its inclusion in the compendium. The extent of method verification depends on the type of method.

During method verification, our analytical scientists perform documented testing demonstrating that the developed analytical method performs adequately for the specific product or matrix being tested and within the specific laboratory where the method will be employed.

Talk to Our Experts or Request a Quote

Our expert team is ready to answer your questions and guide you to the services best suited to your program’s modality, stage and challenge. If your needs are well-defined, we’ll begin the quotation process.

Description

Related Services

Aggregate analytics – Overview Analytical ultracentrifugation (SV-AUC / SE-AUC) Asymmetrical flow field-flow fractionation (AF4) Capillary gel electrophoresis (cGE) Dynamic light scattering (DLS) High-performance size-exclusion chromatography (HP-SEC) Hollow fiber flow field-flow fractionation (HF5) Liquid chromatography coupled mass spectrometry (LC-MS) Nephelometry/Turbidity SDS-PAGE Ultra-high-performance size-exclusion chromatography (UP-SEC)

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