Accelerating the Development of Biosimilars
Sartorius Stedim BioOutsource Ltd. is an industry leader in the characterization and comparability of biosimilar to originator biologics, providing comprehensive, rapid, high-quality testing services to the biopharmaceutical industry. Hear how they have implemented the latest workflow for biopharmaceutical charge variant profiling. Hear how the simplicity, speed and robustness of this workflow enables them to deliver fast answers for drug developers.
Using the NISTmAb reference standard to demonstrate a simple approach to charge variant analysis
The aim of this work was to demonstrate the effectiveness of a simple pH gradient/ion-exchange chromatography workflow approach to the characterization of charge variants in monoclonal antibodies using the NISTmAb reference standard as a model analyte. To show the assay is simple, reproducible, easily optimized, and resolves variants more effectively than previously published salt gradients.
Evaluation and application of salt- and pH-based ion-exchange chromatography gradients for analysis of therapeutic monoclonal antibodies
The goal of this work was to demonstrate a simple, easily prepared pH buffer system that is capable of charge variant determination for the majority of therapeutic monoclonal antibody species. To show the ease of optimization and improved reproducibility of the CX-1 pH gradient buffer system when compared to salt-based gradient systems used for charge variant analysis.
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The aim of this study was to demonstrate the effectiveness of a simple pH gradient/ion-exchange chromatography workflow approach to the characterization of the different charge variants profiles of an innovator molecule (cetuximab) and a candidate biosimilar. To show the assay is simple, reproducible, easily optimized and resolves variants effectively.
Therapeutic proteins are complex, requiring a multitude of physicochemical tests to elucidate structure. Sartorius Stedim BioOutsource focuses on high quality, high resolution data to support biosimilar clients in the endeavor to prove ‘fingerprint-like’ structural similarity, including charge variant profiling, aggregate analysis, glycan analysis, intact mass analysis, and peptide mapping.
This is a weak cation exchange (WCX) liquid chromatography column designed for protein characterization including therapeutics such as monoclonal antibodies (mAbs). WCX chromatography is primarily used for the separation and quantitation of mAb and other protein charge variants that can arise during cellular production, downstream purification, storage and shipping. This unique column chemistry provides excellent performance under a broad range of pH, temperature and mobile phase compositions with excellent recovery and low carryover. 
Optimize your challenging characterization using the unique Thermo Scientific™ ProPac™ Elite WCX weak cation exchange (WCX) liquid chromatography column which demonstrates excellent reproducibility and durability under a broad range of pH, temperature and mobile phase compositions.
