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Measurement of impurities to support process development and manufacture of biopharmaceuticals

Research paper by SheunOshinboluab, Louisa J.Wilsonab, WillLewisb, RachanaShahb, Daniel G.Bracewella

Indexed on: 23 Nov '17Published on: 01 Nov '17Published in: Trends in Analytical Chemistry



Abstract

•Impurities in biopharmaceuticals affect drug quality, efficacy and patient safety.•These impurities need to be tightly controlled to meet ICH regulatory guidelines.•Aggregates, HCPs and glycosylation are typical critical quality attributes.•Critical quality attributes need to be controlled with appropriate analytical assays.