Experience with host cell protein impurities in biopharmaceuticals

• Published in: Biotechnology progress Vol. 34; no. 4; pp. 828 - 837
• Main Authors: Vanderlaan, Martin, Zhu‐Shimoni, Judith, Lin, Sansan, Gunawan, Feny, Waerner, Thomas, Van Cott, Kevin E.
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.07.2018
• Subjects: Animals; Biological activity; Biological Products - analysis; Biopharmaceuticals; Chinese Hamster Ovary proteins; CHO Cells; Chromatography, Liquid; clinical responses; Cricetinae; Cricetulus; Enzyme-Linked Immunosorbent Assay; Homology; host cell proteins; Humans; Immunogenicity; Impurities; Inserts; Organic chemistry; product stability; Proteins; Proteins - analysis; Tandem Mass Spectrometry; clinical responses; host cell proteins; Chinese Hamster Ovary proteins; impurities; immunogenicity; product stability

In the 40‐year history of biopharmaceuticals, there have been a few cases where the final products contained residual host cell protein (HCP) impurities at levels high enough to be of concern. This article summarizes the industry experience in these cases where HCP impurities have been presented in...