Experience with host cell protein impurities in biopharmaceuticals

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...

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Published inBiotechnology 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
LanguageEnglish
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
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Summary: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 public forums and/or published. Regulatory guidance on HCP impurities is limited to advising that products be as pure as practical, with no specified numerical limit because the risk associated with HCP exposure often depends on the clinical setting (route of administration, dose, indication, patient population) and the particular impurity. While the overall safety and purity track record of the industry is excellent, these examples illustrate several important lessons learned about the kinds of HCPs that co‐purify with products (e.g., product homologs, and HCPs that react with product), and the kinds of clinical consequences of HCP impurities (e.g., direct biological activity, immunogenicity, adjuvant). The literature on industry experience with HCP impurities is scattered, and this review draws in to one reference documented examples where the data have been presented in meetings, patents, product inserts, or press releases, in addition to peer‐reviewed journal articles. © 2018 American Institute of Chemical Engineers Biotechnol. Prog., 34:828–837, 2018
Bibliography:ObjectType-Article-2
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ObjectType-Review-1
ISSN:8756-7938
1520-6033
DOI:10.1002/btpr.2640