mAbs Characterization & Quality Control

The key for ensuring drug saftey and efficacy

HomeIntegrated OfferingsMonoclonal Antibodies (mAbs)Characterization and Quality Control

Characterization and quality control of monoclonal antibodies (mAbs) is critical throughout the mAb workflow. It involves a series of quality control tests and assays to evaluate the physical and chemical properties of the mAb. These parameters are strictly monitored with mass spectrometry-based methods for quantitative and qualitative antibody characterization to determine the primary sequence, post-translational modifications (PTMs), charge variants, and other properties that can potentially impact the efficacy, stability, half-life, and safety of therapeutic mAbs.

Characterization and Quality Control

Intact Mass Analysis

Peptide Mapping

Post-Translational Modification Analysis

Aggregate Analysis

Titer Determination

Microbiological Testing

Characterization and Quality Control of Monoclonal Antibodies

Our comprehensive portfolio of high-quality products for peptide mapping, post-translational modification, intact mass analysis, titer determination analysis, and aggregate analysis provides everything you need for the characterization and analysis of monoclonal antibodies (mAbs) to reliably evaluate critical quality attributes (CQAs) and ensure mAb quality and efficacy.

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HPLC column is installed in lab instrument. The hands of a lab worker are shown wearing blue nitrile gloves.

Analytical Chromatography

Discover our premium products for accurate results in HPLC, GC, and more.

Dark-haired female lab worker wearing safety goggles, white lab coat and blue nitrile gloves prepares a solution of reagents. Glass vials, glass beakers and a computer screen are visible in the background.

Analytical Reagents

Count on our high-quality reagents for analytical characterization in various stages of mAb production.

Lab with white cupboards and chemistry lab equipment used for quantitative analysis is shown without any people working. Fume hood, glass vials and beakers are visible.

Reference Materials

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

Brochure: HPLC Column Selection Guide
Our selection of columns, solvents, standards and sample preparation products are exclusively designed for HPLC and LC-MS, meeting the critical need for purity.
Brochure: HPLC Method Development Guide
Depending on the type of interaction of the sample molecules with both mobile and stationary phases, different types of interactions can be possible in HPLC.
Brochure: BIOshell™ Columns
The BIOshell™ line of superficially porous particle (SPP) packed columns has been developed to aid research into understanding the subtleties of the molecule that is being developed.
Brochure: Chromolith^® HPLC Columns
The secret to the speed of Chromolith^® columns is their exceptionally low back pressure. Produced from a continuous piece of porous silica using a sol-gel process, Chromolith^® columns possess a defined, bimodal pore structure with macro and mesopores in the micro and nanometer range.
Brochure: Discovery Bio Columns
Discovery^® BIO Wide Pore Reversed Phase HPLC columns and capillaries provide sensitive, stable, efficient, and reproducible separations of proteins and peptides.
Brochure: LC-MS Resource Guide
In this guide, we provide a premier selection of proven Supelco^® tools and consumables that meet the requirements of scientists who primarily use the LC-MS technique for analysis of drugs, biomolecules separation and analytical assays.
Flyer: Advanced LC-MS Solvents
Our new range of advanced UHPLC-MS LiChrosolv^® solvents have been developed to exceed all expectations, providing rapid and reliable results in both ESI/APCI positive and negative ionization modes.
Article: HPLC Method Transfer Calculator
Calculate the saving in run time and solvent consumption when transferring a method from HPLC conditions to UHPLC conditions. Obtain guidance on change in back pressure as well as how to adapt injection volume and gradient conditions.
Application: Bioburden Testing
Bioburden testing measures the levels of microbial contamination in water, raw materials, and finished products.
Application: Surface & Personnel Testing
Surface monitoring and personnel monitoring measure the levels of microbial contamination in production areas to control the measures of disinfection routines.
Article: Media Fill Testing in the Pharmaceutical Industry
High quality granulated and ready-to-use culture media irradiated for accurate and reliable aseptic process simulations.
Article: 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.