Host cell proteins in biotechnology-derived products: A risk assessment framework

Volume: 112, Issue: 11, Pages: 2284 - 2291
Published: Jun 16, 2015
Abstract
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...
Paper Details
Title
Host cell proteins in biotechnology-derived products: A risk assessment framework
Published Date
Jun 16, 2015
Volume
112
Issue
11
Pages
2284 - 2291
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