Capillary Gel Electrophoresis (CGE)
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Based on the separation of macromolecules according to their size, CGE represents one of the reference methods to assess size heterogeneity and glycan profiling of mAbs and ADCs. Creative Proteomics helps clients to comprehensively characterize antibody drugs with our cutting-edge CGE technology and expertise. Our CGE methodology has been widely used in all stages of antibody drug production, including bioprocess development, formulation development, mAb characterization, drug product release testing, and stability testing. Through our high-resolution CGE technology, we fully characterize antibody drugs and provide valuable insights into drug properties.
Introduction of Capillary Gel Electrophoresis
Among CGE techniques, Sodium dodecyl sulfate-capillary gel electrophoresis (SDS-CGE) is the adaptation of the sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) methodology converted to a miniaturized capillary format. In SDS-CGE, the gel matrix is contained in a capillary, usually with an inner diameter of 50-100 µm and wall thickness of 50-200 µm. This geometry, when coupled with efficient capillary temperature control, creates efficient dissipation of Joule heating and allows for the application of a high electrophoretic field strength, yielding high-speed and high-resolution separations.
Capillary gel electrophoresis can be used to analyze all aspects of antibody drug characterization, including process control and characterization in release and stability testing. Specific applications include:
- N-glycan analysis
- Size heterogeneity analysis
- Estimation of the drug-to-antibody ratio (DAR) of ADC
- Purity assessment
- Stability assessment
- Aggregation assessment
Advantages of Capillary Gel Electrophoresis
- Shorter analysis times, easy automation and higher throughput.
- Compatibility with a wide range of on-line detection strategies and inherently high levels of quantitation.
- Sufficient stability and quantitative reproducibility to support antibody drug development and mAb characterization in QC labs.
Our Capabilities
- CGE method development and validation
Creative Proteomics has expertise in developing and validating CGE methods for antibody drug characterization. Our experts customize and optimize various CGE parameters (buffer systems, gel compositions, etc.) by gaining an in-depth understanding of customer requirements and objectives. We also validate CGE methods for antibody drug characterization against regulatory requirements to ensure the robustness, accuracy, precision, and specificity of the CGE analytical methods provided.
- Antibody drug analysis and characterization using CGE
Through the use of capillary gel electrophoresis, we can perform comprehensive characterization of antibody drugs, including determination of molecular weight, purity, charge heterogeneity and aggregation analysis. This enables us to help our customers assess the quality, stability and integrity of antibody drugs at all stages of development and production.
Our experts perform comprehensive data analysis of CGE results, generating quantitative and qualitative information for the identification of impurities, aggregates, charge variants, glycosylation patterns, and more. These results can be used for statistical analysis for lot-to-lot comparisons, stability studies, etc. of antibody drugs.
Creative Proteomics is committed to providing reliable data using powerful capillary gel electrophoresis technology to support your antibody drug development process. Our state-of-the-art CGE platform, combined with our experienced team, ensures high-quality results to facilitate successful antibody drug development and commercialization. Contact us to learn more about our service and we will be happy to serve you.
