mAbs Characterization & Quality Control
The key for ensuring drug safety and efficacy
Characterization and quality control of monoclonal antibodies (mAbs) is essential to ensure their efficacy and safety. Analytical techniques, like HPLC and mass spectrometry, are vital to assess various properties, such as aggregation, charge variants, and post-translational modifications (PTMs). Our extensive selection of products supports the detailed analysis and evaluation of mAbs to maintain quality and effectiveness.
Aggregate Analysis of Monoclonal Antibodies
Explore our wide range of high-quality products for aggregate analysis of monoclonal antibodies (mAbs), designed to reliably ensure the consistency and quality of monoclonal antibody products.
Our size-exclusion chromatography (SEC) columns provide fast and reliable determination of protein aggregate content in the analysis of mAbs. These columns are available in different sizes, lengths, pore diameters, and particle sizes, depending on the sample size, resolution, and sensitivity required for the separation and analysis of the molecules of interest.
Our high-purity solvents further guarantee accuracy by minimizing impurities that affect analysis, while HPLC-grade buffers mitigate pH fluctuations in the mobile phase. Supelco®, NIST, EP, and USP monoclonal antibody reference standards support consistency and reproducibility in antibody assays.
Related Categories
Size-exclusion chromatography (SEC) columns reliably determine protein aggregate content in mAbs.
Use our highest grade of solvents in mAb production to minimize the risk of impurities.
Choose the right HPLC grade buffers for precise size exclusion chromatography.
Explore a wide range of standards for use in Biopharma.
Related Articles
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A complete workflow for the intact and middle-up mass analysis of reduced and non-reduced monoclonal antibodies based on SEC-MS with sample preparation by protein-A affinity clean-up.
- /PH/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/essential-methods-for-monoclonal-antibody-characterization
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HPLC separates and identifies large biomolecules like proteins and peptides by pumping the sample through a sorbent-packed column.
- Peptide Mapping LC-MS/MS Analysis Workflow for Adalimumab
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- Biopharmaceutical Characterization
Large biomolecules, biologics, biosimilars, vaccines present challenges in characterization and quantification. Since product characterization is the foundation of safe biological drug development, continuous improvement of techniques and applications ensure efficient characterization and manufacturing of the drug.
- HPLC Analysis of mAb Aggregates on TSKgel® UltraSW Aggregate: Effect of Mobile Phase Additives on Resolution
- /PH/en/technical-documents/technical-article/analytical-chemistry/wet-chemical-analysis/milli-q-iq7003-7005
Related Webinars
Learn how to enable and maintain high quality and high sensitivity in LC-MS analyses by preventing impurities and contaminations.
Explore a simple and high throughput method for the quantitation of monoclonal antibodies and proteins in human and animal serum.
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