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- W2028489320 endingPage "1508" @default.
- W2028489320 startingPage "1494" @default.
- W2028489320 abstract "Monoclonal antibodies have proved to be a highly successful class of therapeutic products. Large-scale manufacturing of pharmaceutical antibodies is a complex activity that requires considerable effort in both process and analytical development. If a therapeutic protein cannot be stabilized adequately, it will lose partially or totally its therapeutic properties or even cause immunogenic reactions thus potentially further endangering the patients' health. The phenomenon of protein aggregation is a common issue that compromises the quality, safety, and efficacy of antibodies and can happen at different steps of the manufacturing process, including fermentation, purification, final formulation, and storage. Aggregate levels in drug substance and final drug product are a key factor when assessing quality attributes of the molecule, since aggregation might impact biological activity of the biopharmaceutical. In this review it is analyzed how aggregates are formed during monoclonal antibody industrial production, why they have to be removed and the manufacturing process steps that are designed to either minimize or remove aggregates in the final product." @default.
- W2028489320 created "2016-06-24" @default.
- W2028489320 creator A5000802262 @default.
- W2028489320 creator A5026405445 @default.
- W2028489320 date "2011-04-20" @default.
- W2028489320 modified "2023-10-14" @default.
- W2028489320 title "Aggregates in monoclonal antibody manufacturing processes" @default.
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