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Automated MAb Workflow: From Harvest CellCulture to Intact Mass Analysis of Variants
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Recombinant monoclonal antibodies (MAbs) are a growing class of therapeutic molecules. Early in the development of MAbs, a large number of harvest cell culture (HCC) samples must be screened for immunoglobulin G (IgG) titer, aggregations, and charge variants. This study describes a two-dimensional (2D) high performance liquid chromatography (HPLC) work ow for af nity, size-exclusion, and ion-exchange analysis.
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Assay for Parts-Per-Million Levels of Azide in Drug Substances
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The removal of azide as a potential impurity from a drug substance may be critical to its safety profile. The quantitation of thi impurity is an important control parameter. This article describes a simple and practical assay for azide using chemical derivatization and HPLC.
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