Faster, Easier, and Better Biopharmaceutical Charge Variant Profiling

 

Learn how patented pH gradient buffer kits enable you to easily produce linear pH gradients for fast and robust therapeutic protein separations.

 

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.

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Using the NISTmAb reference standard to demonstrate a simple approach to charge variant analysis

Using the NISTmAb reference standard to demonstrate a simple approach to charge variant analysisThe 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.

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Evaluation and application of salt- and pH-based ion-exchange chromatography gradients for analysis of therapeutic monoclonal antibodies

Evaluation and application of salt- and pH-based ion-exchange chromatography gradients for analysis of therapeutic monoclonal antibodiesThe 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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