BioPharmaceutical Characterization Resource Center

Improve Your Protein Aggregate Analysis

Therapeutic protein aggregate species can trigger dangerous immunotoxic responses in patients. Confident, fast detection of aggregates is critical for drug product quality. This can be delivered with the Thermo Scientific Protein Aggregate workflow.

The Importance of Correct UHPLC Instrument Setup for Protein Aggregate Analysis by Size-exclusion Chromatography

The goal of this study was to show the applicability of Thermo Scientific™ MabPac™ SEC-1 columns for monoclonal antibody aggregate analysis using the Thermo Scientific™ Vanquish™ Flex Quaternary UHPLC system.

A Universal Chromatography Method for Aggregate Analysis of Monoclonal Antibodies

Analysis of protein aggregation of five important biotherapeutic monoclonal antibodies (mAbs) by size-exclusion chromatography, showing the universal applicability of the Thermo Scientific™ MAbPac™ SEC-1 column for aggregate analysis of mAbs. The aims of this study were to produce a single globally applicable SEC chromatography method for the five mAb samples, show peak symmetry (implying limited secondary interaction with the column), and maintain the required monomer and dimer. resolution.

[eBook] Methods & Applications in BioPharmaceutical Characterization

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Intact Protein Analysis
Monoclonal Subunit Mass Analysis
Peptide Mapping Analysis
Peptide Mapping
Labeled Glycan Analysis
Unlabeled Glycan Analysis
Aggregate Analysis
Charge Variant Analysis

High-throughput protein aggregate analysis of monoclonal antibodies using a novel dual-channel UHPLC instrument

To demonstrate the high-throughput capabilities of the newly developed Thermo Scientific™ Vanquish™ Flex Duo UHPLC system for Dual LC. This study focused on data reproducibility and the quality of chromatography, while comparing technology performance to the standard Thermo Scientific™ Vanquish™ Flex Quaternary UHPLC system.

HIC as a Complementary, Confirmatory Tool to SEC for the Analysis of mAb Aggregates

To demonstrate the analysis of monoclonal antibody (mAb) aggregates using the Thermo Scientific™ MAbPac™ SEC-1 and MAbPac™ HIC-10 columns. The MAbPac SEC-1 column provides fast and high-resolution separation of mAb aggregates from the monomer. The MAbPac HIC-10 column provides excellent separation of mAb aggregates from the monomer and the ability to resolve mAb variants.

Lifetime stability of size exclusion chromatography columns for protein aggregate analysis

The aim of this work was to demonstrate the long-term stability of the Thermo Scientific™ MAbPac™ SEC-1 column for monoclonal antibody aggregate analysis using the Thermo Scientific™ Vanquish™ Flex Quaternary UHPLC system.