Bioreactor process parameter screening utilizing a Plackett-Burman design for a model monoclonal antibody

Journal of Pharmaceutical Sciences
Cyrus AgarabiErik K Read

Abstract

Consistent high-quality antibody yield is a key goal for cell culture bioprocessing. This endpoint is typically achieved in commercial settings through product and process engineering of bioreactor parameters during development. When the process is complex and not optimized, small changes in composition and control may yield a finished product of less desirable quality. Therefore, changes proposed to currently validated processes usually require justification and are reported to the US FDA for approval. Recently, design-of-experiments-based approaches have been explored to rapidly and efficiently achieve this goal of optimized yield with a better understanding of product and process variables that affect a product's critical quality attributes. Here, we present a laboratory-scale model culture where we apply a Plackett-Burman screening design to parallel cultures to study the main effects of 11 process variables. This exercise allowed us to determine the relative importance of these variables and identify the most important factors to be further optimized in order to control both desirable and undesirable glycan profiles. We found engineering changes relating to culture temperature and nonessential amino acid supplementation si...Continue Reading

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Citations

Apr 5, 2016·BioMed Research International·Brittany K ChavezKurt A Brorson
Mar 27, 2016·Trends in Biotechnology·Sha ShaSeongkyu Yoon
Aug 31, 2016·International Journal of Pharmaceutics·Hemlata BhatiaSeongkyu Yoon
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Jul 16, 2017·Biotechnology and Bioengineering·Mo JiangRichard D Braatz
Mar 3, 2019·Engineering in Life Sciences·Eduard Puente-MassaguerFrancesc Gòdia

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