Charge Variant Analysis of USP Monoclonal Antibody Reference Standards
There are multiple analytical techniques like ion exchange chromatography (IEX), Capillary isoelectric focusing (cIEF) or imaged capillary isoelectric focusing (icIEF) used for charge variant analysis. This technote is focused on cIEF and icIEF which are commonly used analytical methods for charge variant analysis.
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Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
