Ion Exchange Chromatography (IEX)

Ion exchange chromatography is a widely used and powerful analytical technique for the comprehensive characterization of antibody drugs, especially for qualitative and quantitative characterization of charge heterogeneity. Creative Proteomics is committed to providing our customers with high-throughput advanced characterization techniques in antibody drug characterization to ensure the delivery of accurate and reliable results. With years of experience in developing ion exchange chromatography methods, we are pleased to customize IEX methods to provide expertise and technical support to our customers in the characterization of antibody drugs.

Applications of Ion Exchange Chromatography

Ion exchange chromatography is a powerful analytical technique used for the separation and purification of biomolecules, such as proteins and antibodies. This technique relies on the reversible adsorption of charged molecules onto the ion exchange resin, based on their net charge. By controlling the pH and ionic strength of the mobile phase, the biomolecules can be selectively eluted from the resin. In the characterization of antibody drugs, ion exchange chromatography is commonly used to determine the charge heterogeneity of the antibodies, which may arise from post-translational modifications or manufacturing processes. By analyzing the elution profiles of the different charge variants, ion exchange chromatography provides valuable information on the structural integrity and quality of the antibody drug. Ultimately, this technique aids in the production and quality control of antibody drugs, ensuring their safety and efficacy in therapeutic applications.

• Separation of mAb variants
• Analysis of antibody-drug conjugates

Advantages of Ion Exchange Chromatography

• Excellent separation capability and stability over a wide range of sample volumes and concentrations.
• High resolution, separation by charge difference, enables detection and characterization of different antibody species such as fragments, aggregates, variants and impurities.
• Wide range of applications for characterizing antibody drugs at different stages of development, including clone selection, process optimization and batch release testing.

Our Capabilities

• Advanced IEX characterization techniques

Creative Proteomics offers different IEX techniques available for antibody drug characterization, including traditional strong/weak anion/cation exchange chromatography, mixed-mode, and multimodal IEX., as well as the ability to be used in conjunction with other detection techniques. This gives us the ability to provide the most suitable detection technique according to our customers' demands.

• Method development and validation

Our skilled and experienced project specialists work closely with our customers to customize and optimize IEX methods to suit their sample and assay demands, ensuring reliable and accurate characterization results. In addition, all tests and methods are validated under regulatory guidelines to ensure the reliability and compliance of the developed methods.

• Assay conditions optimization

We understand the importance of assay conditions in obtaining accurate and sensitive IEX results. Our optimization services include the selection of custom stationary phase packing and sizing, mobile phase conditions (pH, salt properties and concentration) as well as temperature and flow rate to enhance the separation and detection of antibody drugs.

Creative Proteomics is committed to providing our customers with advanced analytical technologies and complete antibody drug characterization information to accelerate their drug development programs. Contact us to learn more about our service and we will be happy to serve you.