Product variants are contaminants because they bear properties that are different from those of desired biological products with respect to activity, efficacy, and safety. Thus, such variants can compromise product quality and consistency. In this eBook, Yuval Shimoni explores different types of variants — including primary-sequence variants, undesirable posttranslational modifications, aggregates, and degraded proteins — and explains how their presence can diminish the performance and quality of drug substances and products. He also discusses how product variants form at different process development stages and in response to manufacturing changes, highlighting some of the chromatographic, spectrometric, and electrophoretic methods that analysts use to detect and characterize them. Underscoring the importance of variant detection for both existing and emergent biopharmaceuticals, Shimoni anticipates how such screening technologies and practices might be applied to the characterization of mRNA-based products, including some of the SARS-CoV-2 vaccines that regulatory agencies have authorized for emergency use.
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