FEATURES
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Mass spectrometry-based attribute monitoring assays have been proposed as key tools to provide the sensitivity, throughput, selectivity, and flexibility required for monitoring critical product and process attributes for biopharmaceutical production and release. Subunit multi-attribute monitoring (MAM) and peptide MAM have emerged to dominate this discussion, and this article is intended to reflect on the active debates over the needs, challenges, and practical limitations for adopting MS-based attribute monitoring for late-development and QC. read more
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This article describes advances in ion exchange column chemistries, elution buffers, and ultrahigh-pressure liquid chromatography (UHPLC) instruments to meet the needs for modern, robust analysis of charge variants in monoclonal antibodies and therapeutic proteins. read more
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More Features
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In recent years, LC–MS/MS methods have been increasingly adopted as a replacement for ligand binding assays to monitor the fate of drugs in vivo. Such bioanalysis of protein-based pharmaceuticals (biopharmaceuticals) is more challenging, however, than it is for small-molecule drugs. Rainer Bischoff of the University of Groningen in the Netherlands has been exploring approaches to overcome these challenges. He recently spoke to us about this work. read more
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NEWS
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Researchers from the Chinese Academy of Science in Beijing, China, have used high performance size-exclusion chromatography (HPSEC) and differential scanning calorimetry (DSC) to study the stabilization of inactivated foot and mouth disease virus. read more
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