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Charge variant and aggregation analysis of innovator and biosimilars of rituximab

Agilent Technologies
27 Jun 2021

Monoclonal antibodies are an important class of biomolecules used for the treatment of various diseases. Biosimilars, the copy versions of an innovator molecule, need to be characterized in detail for their critical quality attributes such as aggregates and charge variants. This application note compares two rituximab biosimilars from different manufacturers to the innovator for their aggregation and charge variant profiles by following two analytical workflows using Agilent 1260 Infinity II Bio-Inert LC and Agilent AdvancedBio columns.

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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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AdvanceBio HIC

Agilent Technologies

Agilent AdvanceBio HIC columns deliver robust and reproducible high-resolution separations of native proteins at the intact level. 

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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.ChromatographyChromatography is a powerful technique used to separate and analyze components of mixtures based on their chemical properties. It is widely used in fields like biochemistry, pharmaceuticals, and environmental analysis. By exploiting differences in the interaction of substances with a stationary phase and a mobile phase, chromatography enables precise purification and quantification of compounds. Whether you're working with complex biological samples or industrial chemicals, chromatography is essential for obtaining high-quality results. Browse our peer-reviewed product directory to find the best chromatography systems, compare products, read customer reviews, and get pricing directly from manufacturers.

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Charge variant and aggregation analysis of innovator and biosimilars of rituximab