mAbs Characterization & Quality Control

The key for ensuring drug safety and efficacy

HomeIntegrated OfferingsMonoclonal Antibodies (mAbs)Characterization and Quality ControlAggregate Analysis

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.

Characterization and Quality Control

Intact Mass Analysis

Peptide Mapping

Post-Translational Modification Analysis

Aggregate Analysis

Titer Determination

Microbiological Testing

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

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HPLC Columns

Size-exclusion chromatography (SEC) columns reliably determine protein aggregate content in mAbs.

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High-Purity Solvents

Use our highest grade of solvents in mAb production to minimize the risk of impurities.

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Mobile-Phase Buffers & Buffer Salts

Choose the right HPLC grade buffers for precise size exclusion chromatography.

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Amino Acid, Peptide & Protein Standards

Explore a wide range of standards for use in Biopharma.

Protocol for Purification, Optional Reduction, and SEC-MS Analysis of a Monoclonal Antibody
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.
Three Methods for Critical Quality Attribute Determination of Monoclonal Antibodies
Step-by-step workflows for the intact mass analysis, peptide mapping, and N-glycan analysis of the monoclonal antibody― adalimumab, for an accurate characterization of the critical quality attributes (CQAs) to ensure drug safety and efficacy. Read more.
Large Molecule HPLC
High performance liquid chromatography (HPLC) can be used to separate and identify different large biomolecules such as protein and peptides in a sample. It is based on the pumping of a sample with a solvent (mobile phase) through a column packed with sorbent material (stationary phase) at a high pressure.
Peptide Mapping LC-MS/MS Analysis Workflow for Adalimumab
An optimized LC-MS/MS based workflow for low artifact tryptic digestion and peptide mapping of monoclonal antibody, adalimumab (Humira) using filter assisted sample preparation (FASP).
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
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Milli-Q^® IQ 7003/05/10/15 Ultrapure & Pure Lab Water Purification System
Milli-Q® IQ 7003/05/10/15 lab water systems provide consistent-quality Type 1 and Type 2 water, are intuitive to use, and can support your lab's sustainability goals.