Ion-Exchange Chromatography

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Ion-Exchange Chromatography

Method Introduction

Ion-exchange chromatography (IEX) is a widely used, high-throughput analytical technique that separates analytes based on differences in net surface charge and charge distribution.

Therefore, the technique does not require organic solvents and is frequently applied to characterize proteins in their native/active form. We offer IEX on high-performance liquid chromatography (HPLC) instruments coupled with UV-, fluorescence and refractive index- detection.

Applications

We are experienced in performing IEX on a large selection of columns from various vendors, offering different bead sizes, matrix materials and functional groups. For each method mobile phase compositions, particularly salt concentration and pH, are specifically optimized. With many years of experience developing IEX methods, we are happy to apply our know-how while developing a tailor-made IEX method for you.

Quality and Biosafety Level

We provide all our analytical services with the highest quality standards. Experienced scientists carry out each project, and a scientific reviewer comprehensively checks every report or data presentation.

We offer this technology with the following quality and biosafety levels:

Up to GMP Level

This method is available under GMP in dedicated labs with qualified equipment and full QA involvement.

Up to biosafety level 2

This method can be applied to nucleic acids, viruses, cells, viral vectors, including lentiviruses and more.

Ion-Exchange Chromatography (IEX) Frequently Asked Questions (FAQs)

  • Ion-exchange chromatography (IEX) is a high-resolution separation technique that relies on differences in net surface charge to purify and analyze biomolecules. Charged species interact with functional groups on the chromatography matrix, and are eluted based on changes in salt concentration or pH.

  • IEX is commonly used for the separation and characterization of proteins, peptides, nucleic acids, viral vectors, and other charged macromolecules. It is especially valuable for evaluating charge variants, isoforms, and post-translational modifications.

  • IEX enables high-throughput, solvent-free analysis of proteins in their native conformation. It is a powerful tool for detecting charge heterogeneity, confirming protein identity, and monitoring purity or degradation products during formulation development and stability studies.

  • Coriolis has extensive experience with a broad selection of IEX columns varying in bead size, matrix material, and functional groups. Our scientists optimize salt gradients, pH conditions, and detection modes—such as UV, fluorescence, or refractive index—to develop molecule-specific methods.

  • Yes. Ion-exchange chromatography is available up to GMP level at Coriolis Pharma, performed in qualified laboratories using validated equipment and full quality assurance oversight.

  • Yes. IEX is compatible with biologic materials up to biosafety level 2 (BSL-2), including nucleic acids, viral particles, and gene therapy vectors such as lentivirus.

  • While reversed-phase HPLC separates analytes based on hydrophobicity and cIEF focuses on isoelectric point, IEX specifically targets charge-based separation. It is often used alongside these orthogonal techniques to build a comprehensive analytical profile of complex biologics.

  • Absolutely. IEX is frequently used to monitor the consistency of charge profiles across batches, detect degradation or impurity species, and support comparability assessments during formulation changes or lifecycle management.

  • Coriolis offers customized IEX method development backed by deep formulation expertise and robust quality standards. Our ability to integrate IEX with orthogonal analytical platforms provides actionable data for product development, regulatory support, and lifecycle management.

Analytical Method Development, Qualification and Validation

For common sample types, we can often apply standardized methods with little setup effort. However, when needed, our experienced analytical experts create or optimize custom methods tailored to your active pharmaceutical ingredient, product type and development phase.

Method Development

Our method development approach tailors sample preparation, method settings and data analysis to the needs of your project and sample.

We include representative samples and, where available, suitable reference standards and stressed/degraded materials, allowing our analytical scientists to design a highly suitable, stability-indicating, robust and repeatable method. Upon request, we will compile a detailed description of the method for your records.

Method Qualification

Method qualification is the initial assessment of an analytical procedure’s performance to show its suitability for its intended purpose.

During method qualification, our analytical scientists perform documented testing demonstrating that the analytical procedure meets criteria in several categories. Criteria may include factors such as repeatability, specificity and robustness. We compile a qualification plan and report, including all relevant data.

Method Validation

Under GMP conditions, method validation confirms that an analytical procedure’s performance suits its intended purpose. Depending on the method’s scope, a broad range of method characteristics, such as specificity, accuracy, precision, limit of detection/limit of quantification (LOD/LOQ), linearity and range, is considered.

During method validation, our analytical scientists perform documented testing demonstrating that the analytical procedure consistently produces a result that meets the predetermined acceptance criteria. We compile a validation plan and report that includes all relevant data.

Depending on the development phase, a fit-for-purpose validation approach can be offered, adjusting the validation required efforts in a phase-appropriate way to meet the method’s needs.

Method Verification

Compendial method verification confirms that a compendial method (e.g., from Ph. Eur. or USP) is suitable and reliable for its intended purpose under the specific conditions of the laboratory.

Unlike full method validation, compendial method verification is often considered a partial validation since the method has already undergone extensive testing and validation during its inclusion in the compendium. The extent of method verification depends on the type of method.

During method verification, our analytical scientists perform documented testing demonstrating that the developed analytical method performs adequately for the specific product or matrix being tested and within the specific laboratory where the method will be employed.

Talk to Our Experts or Request a Quote

Our expert team is ready to answer your questions and guide you to the services best suited to your program’s modality, stage and challenge. If your needs are well-defined, we’ll begin the quotation process.

Description

Related Services

Chemical Changes – Overview Capillary isoelectric focusing (cIEF) Ion-exchange chromatography (IEX) Liquid chromatography coupled mass spectrometry (LC-MS) Reversed-phase chromatography (RP-HPLC / RP-UPLC)

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