Charge Variant Analysis

Biotherapeutic proteins such as monoclonal antibodies (mAbs) are far more heterogeneous than small-molecule drugs. The presence of the charged state can significantly impact the structure, stability, binding affinity, and efficacy of the biotherapeutic drug. It is therefore necessary to understand the profile of the drug so that charge variants are identified and removed if necessary.

Achieve robust and reproducible gradients using Thermo Scientific pH Gradient Buffer platform. They are applicable to a wide range of mAbs and ready to use with existing LC columns and systems—including the Thermo Scientific Vanquish Flex UHPLC system—without the need to formulate mobile phases. The pH gradient platform saves time in method development and facilitates method transfer to QA/QC for a wide range of mAb charge variants through a generic LC-based approach to mAb characterization.

• View CX-1 pH buffer specifications
• See separation of denosumab variants using CX-1 pH buffer kits
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The gold standard column for charge variant profiling of monoclonal antibodies is widely regarded  as the Thermo Scientific ProPac WCX-10. ProPac columns resolve isoforms that differ by a single charged residue. A thin, hydrophilic layer grafted to the particle core eliminates unwanted secondary interactions. The cation-exchange surface provides pH-based selectivity control and fast mass transfer for high-efficiency separation and moderate capacity.

We developed our next generation cation exchange column to extend column lifetime and method robustness - the Thermo Scientific MAbPac SCX-10 LC Column is for high-resolution, high efficiency analysis of monoclonal antibodies (mAbs) and associated variants. The unique nonporous pellicular resin provides the resolving power to separate mAb variants. A hydrophilic layer surrounds polymeric beads and eliminates hydrophobic interactions with the resin, resulting in very efficient peaks. A proprietary grafted cation-exchange surface provides pH selectivity control for high-resolution separations.

Speed and accuracy are key criteria for laboratories performing charge variant profiling. Especially in contract research organizations who deliver confident, fast analytical services to the biopharmaceutical and biosimilar industry. Laboratories like Sartorius Stedim BioOutsource have created a niche within the industry, dedicated to rapid structural evaluation of biosimilar monoclonal antibodies (mAbs). Hear from BioOutsource about how the Thermo Scientific Charge Variant Workflow allows them to easily and robustly analyze a range of mAbs using a single platform ph gradient IEX method.

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Obtain new benchmarks in accuracy, precision, and sensitivity in a biocompatible UHPLC system with state-of-the-art quaternary solvent blending. The Thermo Scientific Vanquish Flex Quaternary UHPLC system shares all the values inherent to the Vanquish product line, including an innovative design, focus on uptime, robustness, and reliability. Multiple detection options as well as Thermo Scientific Viper Fingertight Fitting connections throughout the system give you the performance you need with the ease of use you want. The combination makes this system ideal for biopharmaceutical and pharmaceutical applications.

•  Download Vanquish Flex UHPLC brochure
•  Learn more about UHPLC built for biopharma

Streamline your laboratory workflow using Thermo Scientific Chromeleon 7.3 CDS software. This software delivers superior instrument control, automation, and data processing for compliant GxP biopharmaceutical manufacturing and QA/QC environments.

Run your routine HPLC, UHPLC, or LC-MS protein charge variant analyses in an enterprise environment—from method creation to final reporting.