Monday, August 11, 2008
P6

From the lab to the factory: evaluating new fermentation technologies in commercial production

Rick Johnston, Center for Biopharmaceutical Operations, University of California at Berkeley, 4th floor, Etcheverry Hall, Berkeley, CA 94704

One of the key difficulties with evaluating new fermentation technologies in biopharmaceutical production is a robust method of evaluating how they will perform in the context of specific plant operations. There is emerging evidence that focusing on technology changes at a Unit Operation level fails to accurately model how the plant as a whole will perform. We present data suggesting that high levels of variability are one of the key reasons for this gap between performance evaluations at a bench scale, and performance at commercial scale. A more holistic methodology is suggested for modeling the effect of new technologies on plant operations and overall economics based around discrete event simulation. This framework allows a robust evaluation of new technologies, since it captures both the effect of variability in plant operations as well as modeling the effect of limited resources. 

We discuss the methodology in the context of a case study related to simulation of scale-up and fermentation of biopharmaceutical medicines at Genentech. 


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