SEC-MALLS for Antibody Drug Characterization

Size-exclusion chromatography with multi-angle laser light scattering (SEC-MALLS) enables direct measurement of the hydrodynamic properties of substances in solution. It unites the separation capacities of size-exclusion chromatography (SEC) with the detection capabilities of multi-angle laser light scattering (MALLS). MALS data, combined with data from UV, light scattering, and refractive index, allows for the analysis of absolute molar mass and radius of gyration of particles in the solution. A complete analysis of the chromatogram can also determine the nature of substances in the solution, such as dimers, trimers, homogeneity, and other properties. Creative Proteomics offers antibody drug characterization services using SEC-MALLS technology to precisely evaluate the purity, aggregation state, and molecular weight distribution of antibody drugs. These information plays a crucial role in the successful development of antibody drugs.

Principles of SEC-MALLS

MALS is a method for determining the precise molecular weight of proteins by establishing a direct correlation between their molecular weight and the intensity of light scattering, and without the requirement of standard proteins or dependence on elution volume. After separation via SEC, each component enters a multi-angle light scattering detector (MALS), where the laser hits the analyte and creates light scattering. MALS determines the intensity of the scattered light from multiple angles simultaneously. The molecular weight of the molecule to be detected can be calculated based on the intensity of the scattered light. As a result, SEC-MALS technology has broad applications in analyzing proteins and polymers, assessing the purity of antibody drugs, and enhancing process development and quality control.

Fig. 1 Diagram of an SEC-MALLS system. (Moraes, I. et al., 2015)

Our SEC-MALLS -Based Antibody Drugs Characterization Services

Our SEC-MALLS technology is a potent tool for characterizing antibody drugs, revealing key insights into their structural and biophysical properties.

By using SEC-MALLS, we can offer the following services to our customers:

Molecular Weight Determination

SEC-MALLS accurately measures the molecular weight of antibody drugs, providing crucial information about their oligomeric state and potential aggregation.

Stability Analysis

This technique enables the characterization of the size distribution profile of antibody drugs, distinguishing monomeric forms from higher-order aggregates. This helps assess the stability and potential tendency for aggregation.

Aggregate Analysis

SEC-MALLS quantifies the level of aggregation in antibody drugs, providing valuable information during the development and manufacturing processes. It determines the percentage of aggregates and their sizes accurately.

Purity Analysis

SEC-MALLS provides insights into the presence of impurities, such as small molecules or other protein contaminants that may be present in the antibody drug preparation. This ensures the product's purity and aids in quality control.

Advantages of Our SEC-MALLS Technology

• Absolute molecular weight is determined directly by laser scattering intensity, providing information on a wide range of impurities or aggregates.
• Molecular weight determination is not dependent on elution volume or retention time.
• High sensitivity to detect and quantify low levels of aggregates and impurities in sample molecules.

Creative Proteomics' SEC-MALLS technology uses state-of-the-art instrumentation and customized methods to ensure accurate and reproducible analytical results. Our proficient team of researchers and analysts furnishes you with inclusive reports that empower you to understand antibody drugs' structure and aggregation-related information. Contact us to learn more about our service and we will be happy to serve you.

Reference

1. Moraes, I.; et al. Methods for the successful crystallization of membrane proteins. Structural Proteomics: High-Throughput Methods. 2015: 211-230.