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

Author:

de Zafra Christina L. Zuch1,Quarmby Valerie2,Francissen Kathleen3,Vanderlaan Martin4,Zhu-Shimoni Judith5

Affiliation:

1. Safety Assessment; Genentech, Inc.; South San Francisco California

2. Bioanalytical Sciences, Genentech, Inc.; South San Francisco California

3. Pharma Technical Regulatory, Genentech, Inc.; South San Francisco California

4. Analytical Operations, Genentech, Inc.; South San Francisco California

5. Protein Analytical Chemistry, Genentech, Inc.; South San Francisco California

Publisher

Wiley

Subject

Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Reference44 articles.

1. Transforming Growth Factor-b1 is constitutively secreted by Chinese Hamster Ovary cells and is functional in human cells;Beatson;Biotechnol Bioeng,2011

2. Treatment of pituitary dwarfism with biosynthetic growth hormone;Bierich;Acta Pediatr Scand Suppl,1986

3. Pediatric influenza vaccination: Understanding the T-cell response;Bodewes;Expert Rev Vaccines,2012

4. Identification and monitoring of host cell proteins by mass spectrometry combined with high performance immunochemistry testing;Bomans;PLoS ONE,2013

5. Defining your product profile and maintaining control over it, part 2: Challenges of monitoring host cell protein impurities;Champion;Bioproc Int,2005

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