Protein Aggregate Analysis

Rapidly determine protein aggregation

Aggregation of therapeutic proteins can result in an incorrect drug dosage, or and undesired and potentially fatal immune response. Consequently, monitoring protein aggregates is important for safety and quality assurance.

Investigators routinely use size-exclusion chromatography (SEC), which separates particles according to hydrodynamic size. Recently the use of hydrophobic interaction chromatography (HIC) has also received great interest as an orthogonal technique to SEC.

HIC separates proteins based on the hydrophobicity in the native state and can often detect changes in protein structure as well as aggregates.

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Protein aggregation assay workflow

Protein aggregation assay workflow

Protein aggregation analysis categories
SEC for protein aggregation detection

Use Thermo Scientific MAbPac SEC-1 Size Exclusion Columns for high-resolution separation of monoclonal antibody (mAb) analysis, including the monomers, aggregates and Fab and Fc fragments resulting from proteolysis. These size exclusion chromatography (SEC) columns provide superior performance, even under non-denaturing conditions, and in high- and low-salt mobile phases and volatile eluents. 

HIC for determining aggregation and variants of therapeutic proteins

Now you can use a column specifically designed for the separation of monoclonal antibodies (mAbs) and related biologics by hydrophobic interaction (HIC). The Thermo Scientific MAbPac HIC-10 LC high- resolution silica column has a unique chemistry that provides excellent biocompatibility, and selectivity that is different from other HIC columns on the market. Unlike SEC columns, this column separates by hydrophobicity and resolves the different isomeric forms of higher order structures.

Chromatography system built for biopharma characterization

Obtain new benchmarks in accuracy, precision, and sensitivity in a biocompatible UHPLC system with state-of-the-art quaternary solvent blending. The Thermo Scientific Vanquish Flex Quaternary UHPLC system shares all the values inherent to the Vanquish product line, including an innovative design, focus on uptime, robustness, and reliability. Multiple detection options as well as Thermo Scientific Viper Fingertight Fitting connections throughout the system give you the performance you need with the ease of use you want. The combination makes this system ideal for biopharmaceutical and pharmaceutical applications, including the separation of aggregates and other higher order structures.

Software designed for routine GMP protein aggregation analysis

Perform your protein aggregation assays in an enterprise environment—from method creation to final reporting. Streamline your laboratory workflow using Thermo Scientific Chromeleon 7.3 CDS Software. This software delivers superior instrument control, automation, and data processing for compliant GMP biopharmaceutical manufacturing and QA/QC environments.

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