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mAbs Characterization & Quality Control

The key for ensuring drug safety and efficacy

HomeIntegrated OfferingsMonoclonal Antibodies (mAbs)Characterization and Quality ControlPeptide Mapping

 

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

Peptide Mapping of Monoclonal Antibodies

We offer a broad range of high-quality products that are essential for your peptide mapping and critical quality attribute evaluation throughout the monoclonal antibody workflow.

Peptide mapping requires high-efficiency reversed-phase chromatography (RPC) columns to ensure high sequence coverage. We offer a selection of wide-pore, RPC columns designed for peptide mapping.

We offer standards and certified reference materials for mAbs, intact proteins, peptides, amino acids, including SILu™Mab Stable-Isotope Labeled Universal Monoclonal Antibody, for mass spectrometry testing applications.  

We offer a broad portfolio of proteases, cleavage agents, and digestion buffers & kits to facilitate protein digestion. 

  • Low-Artifact Digestion Buffer is optimized for digestion of therapeutic proteins and antibodies prior to peptide mapping by LC-UV-MS.
  • Recombinant Trypsin hydrolyzes peptide bonds specifically at the carboxyl side of arginine and lysine residues and is formulated for in-solution digestion or in-gel digestion and peptide mapping by mass spectrometry.
  • Our SOLu-Trypsin Rapid Digestion Kit provides a fast and efficient method for protein digestion for proteomics.
  • Lys-c (lysyl-endopeptidase) hydrolyzes amide bonds at the carboxylic side of lysine residues.

Related Categories

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HPLC Columns

Discover our wide-pore, RPC columns specifically designed for peptide mapping.

Brown-haired female scientist wearing white lab coat and safety goggles writes a chemical structure on glass screen. Computer screen and lab setting are visible in background.
Amino Acid, Peptide & Protein Standards

Explore our standards and certified reference materials for mass spectrometry testing applications.

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Proteases

Streamline protein digestion to enable advanced analysis and characterization.

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Related Webinars

Tips & Tricks to Improve MS Sensitivity

Learn how to enable and maintain high quality and high sensitivity in LC-MS analyses by preventing impurities and contaminations.

Improving Bioanalysis Workflows

Explore a simple and high throughput method for the quantitation of monoclonal antibodies and proteins in human and animal serum.

Success in Peptide Mapping

Discover tips for bottom-up analysis of mAbs and the role of column chemistry in highly selective HPLC methods.

Related Applications
Viable Air Monitoring
Microbial air monitoring is a critical step in maintaining aseptic environments, cleanrooms and production areas to ensure the quality of raw materials and finished products.
Sterility Testing
Sterility testing is an essential process necessary for sterilization validation. Membrane filtration is a preferred method for sterility testing of pharmaceuticals, food and beverages, tissue materials and other products that claim to be sterile.
Microbial Culture Media Preparation
Culture media provides essential nutrients for the cultivation of microbes. They also contain inhibitors for selective growth of specific microorganisms.
Bioburden Testing
Bioburden testing measures the levels of microbial contamination in water, raw materials, and finished products.
Media Fills
Media fill is a critical microbiological test carried out to assess the performance of an aseptic manufacturing process by replacing the pharmaceutical or beverage product with a sterile culture medium.
Surface & Personnel Testing
Surface monitoring and personnel monitoring measure the levels of microbial contamination in production areas to control the measures of disinfection routines.
Mass Spectrometry
Mass spectrometry (MS) is an analytical tool used to identify compounds, determine chemical structure, and assess isotopic abundance. In MS, samples are ionized, and the resulting ions are identified based on their mass-to-charge (m/z) ratios.
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.

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Immunoglobulin G antibody in blue and yellow
Antibody Drug Discovery
Female lab worker wearing safety goggles and nitrile gloves prepares solution of reagents in beakers with blue and pink liquid.
Characterization & Quality Control
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