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Host cell proteins in biotechnology‐derived products: A risk assessment framework
Author(s) -
de Zafra Christina L. Zuch,
Quarmby Valerie,
Francissen Kathleen,
Vanderlaan Martin,
ZhuShimoni Judith
Publication year - 2015
Publication title -
biotechnology and bioengineering
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.136
H-Index - 189
eISSN - 1097-0290
pISSN - 0006-3592
DOI - 10.1002/bit.25647
Subject(s) - biology , microbiology and biotechnology , function (biology) , recombinant dna , host (biology) , human proteins , computational biology , monoclonal antibody , cell , repertoire , biochemistry , antibody , genetics , gene , physics , acoustics
To manufacture biotechnology products, mammalian or bacterial cells are engineered for the production of recombinant therapeutic human proteins including monoclonal antibodies. Host cells synthesize an entire repertoire of proteins which are essential for their own function and survival. Biotechnology manufacturing processes are designed to produce recombinant therapeutics with a very high degree of purity. While there is typically a low residual level of host cell protein in the final drug product, under some circumstances a host cell protein(s) may copurify with the therapeutic protein and, if it is not detected and removed, it may become an unintended component of the final product. The purpose of this article is to enumerate and discuss factors to be considered in an assessment of risk of residual host cell protein(s) detected and identified in the drug product. The consideration of these factors and their relative ranking will lead to an overall risk assessment that informs decision‐making around how to control the levels of host cell proteins. Biotechnol. Bioeng. 2015;112: 2284–2291. © 2015 Wiley Periodicals, Inc.