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Charge Heterogeneity Analysis of Rituximab Innovator and Biosimilar Monoclonal Antibodies

Agilent Technologies
25 Jan 2018

Recombinant monoclonal antibodies (mAbs) are important biotherapeutics with a wide range of diagnostic and clinical applications. Recently, biosimilar products are increasing in popularity in biopharmaceuticals. This study performs high-resolution separation of charge variants of innovator and biosimilar rituximab using an Agilent 1260 Infinity Bio-inert Quaternary LC, biocolumns, and an Agilent OpenLAB ChemStation Software tool.

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Agilent 1260 Infinity II Bio-Inert LC System

Agilent Technologies

The 1260 Infinity II Bio-Inert LC is a dedicated solution for analysis of large biomolecules in biological samples, including monoclonal antibody (mAb) and protein analysis. Metal-free components in the sample flow path and the absence of iron and steel in solvent delivery lines ensure the integrity of your biomolecules, minimize unwanted surface interactions, and increase column lifetime.

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OpenLAB CDS ChemStation Edition

Agilent Technologies

Offers the most complete instrument control of Agilent LC, GC, CE, CE/MS, and LC/MS instruments systems you have now, with limited instrument control of other vendors’ systems. Plus, take full advantage of the advanced features of the Agilent GC and LC instruments you have now and new instruments, when released.

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.BiosimilarsBiosimilars are very similar versions of approved and authorized medicines. Clinically inactive components will have minor differences, but there are no significant differences between the biosimilar and the original product in terms of potency, purity and safety.BiotherapeuticsBiotherapeutics are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or in <i>in vivo</i> diagnostics. The most well-known example of a biotherapeutic product, and the first to be approved for therapeutic use, was recombinant human insulin.

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