mAbs Characterization & Quality Control

The key for ensuring drug safety and efficacy

HomeIntegrated OfferingsMonoclonal Antibodies (mAbs)Characterization and Quality ControlIntact Mass 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

Intact Mass Analysis of Monoclonal Antibodies

Intact mass analysis of monoclonal antibodies is performed to determine accurate molecular weights of mAb proteoforms for characterization and quality control of the mAb. This technique analyzes mAbs in their intact state using high-resolution mass spectrometry to confirm amino acid composition and detect heterogeneities and glycoforms.

Discover our wide variety of products to monitor the quality and verify consistency in your mAb workflow, including high-performance size-exclusion columns (SEC), ion exchange columns, reversed-phase columns, HPLC buffers, MALDI matrices and standards, high-purity solvents, reagents, tools for protein sample preparation, and reference materials.

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HPLC Columns

Achieve precise separations and characterization with our SEC, ion exchange, and RP columns.

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HPLC Buffers

Reliably couple your analysis directly to the MS with our MS-compatible buffers.

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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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MALDI Matrices and Standards

Analyze critical information on the identity, purity, and structural integrity of mAbs.

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Analytical Reagents

Explore our ELISA kits, Western blotting reagents, and fluorescent dyes for mAb characterization.

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Protein Sample Preparation

Ensure the accuracy and reliability of downstream analytical techniques by isolating the mAb.

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Reference Materials

Use for calibrating and validating analytical methods to ensure high purity and accuracy.

HPLC Columns for Antibody and Large Protein Analysis
BIOshell™ IgG 1000 Å C4 columns are highly suited for the reversed phase separation of high molecular weight compounds such as monoclonal antibodies with molecular weight of 150 kDa.
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.
Fast and high-resolution Analysis of Intact Therapeutic Monoclonal Antibody Trastuzumab using BIOshell™ A400 Protein C4 Column
Optimization of a Reversed-Phase Liquid Chromatographic (RP-LC) method for the intact analysis of a therapeutic monoclonal antibody, trastuzumab, using a BIOshell™ A400 Protein C4 column.
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.
Ultra-Pure MALDI Matrices
One of the most important aspects of our ultra-pure MALDI matrix substances is their ability to dissolve rapidly and completely; a brief vortex mixing is typically sufficient.
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.