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mAbs Characterization & Quality Control

The key for ensuring drug safety and efficacy

HomeIntegrated OfferingsMonoclonal Antibodies (mAbs)Characterization and Quality ControlTiter Determination

 

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

Titer Determination of Monoclonal Antibodies

In the characterization and analysis of monoclonal antibodies (mAbs), titer determination measures the concentration or potency of mAbs in a sample, which is important for maintaining the efficacy and safety of therapeutic mAbs. Protein A affinity chromatography is a powerful tool for the selective capture and purification of mAbs to ensure the consistency and quality of the final product.​

Our high-performance liquid chromatography (HPLC) columns are engineered for protein analysis in titer determination of mAbs. Chromolith® WP 300 Protein A HPLC column is specifically designed to monitor monoclonal antibody titer and yield determination from cell-culture supernatants. This procedure optimizes the monoclonal antibody titer and determines the ideal time for harvesting the monoclonal antibody products. 

Our reliable mobile-phase buffers can be used to carry the sample through the HPLC column to control the separation and elution of mAbs and impurities during the analysis.  Choose from a wide range of HPLC grade buffers to mitigate pH fluctuation in the mobile phase of HPLC. 

Use our highest grade of solvents in mAb production to minimize the risk of impurities. Our high-purity solvents undergo rigorous purification processes and are tested for premium quality to ensure they meet your specifications. 

Related Categories

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HPLC Columns

Monitor mAb titer and yield determination from cell-culture supernatants for ideal harvesting.

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Mobile-Phase Buffers & Buffer Salts

Choose HPLC-grade buffers with the right purity, compatibility, solubility and strength.

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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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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
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Antibody Drug Discovery
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Characterization & Quality Control
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