Exploring the linkage between cell culture process parameters and downstream processing utilizing a plackett-burman design for a model monoclonal antibody

Author:

Agarabi Cyrus D.1,Chavez Brittany K.1ORCID,Lute Scott C.1,Read Erik K.1,Rogstad Sarah2,Awotwe-Otoo David3,Brown Matthew R.1,Boyne Michael T.2,Brorson Kurt A.1

Affiliation:

1. Div. II, Office of Biotechnology Products, Office of Pharmaceutical Quality, CDER; FDA; Silver Spring MD

2. Div. of Pharmaceutical Analysis; Office of Testing and Research, OPQ, CDER, FDA; Silver Spring MD

3. Div. of Post Marketing Activities II; OPQ, CDER, FDA; Silver Spring MD

Publisher

Wiley

Subject

Biotechnology

Reference30 articles.

1. CMC Biotech Working Group A-mab: a case study in bioprocess development 2009 http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/imported/A-Mab_Case_Study_Version_2-1.pdf

2. In vivo crystallization of human IgG in the endoplasmic reticulum of engineered Chinese hamster ovary (CHO) cells;Hasegawa;J Biol Chem.,2011

3. Understanding the intracellular effect of enhanced nutrient feeding toward high titer antibody production process;Yu;Biotechnol Bioeng.,2011

4. Effect of shear stress on expression of a recombinant protein by Chinese hamster ovary cells;Keane;Biotechnol Bioeng.,2003

5. Effect of shear stress on intrinsic CHO culture state and glycosylation of recombinant tissue-type plasminogen activator protein;Senger;Biotechnol Prog.,2003

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