Although the upstream and downstream processes are separated from an organizational standpoint, optimizations in one area may not necessarily lead to reduced costs or improved productivity in the overall process. The results of a series of modeling studies of the production of monoclonal antibodies and viral vaccines are presented. The results indicate that there is an economic limit to the value of increasing product titer in the bioreactor. The studies also show that production bottlenecks may develop in support areas, especially buffer preparation. The effectiveness of several debottlenecking strategies, including in-line buffer dilution and single-use containers, are presented.

Modeling the entire process and finding the production and cost limits

243rd National Meeting (2012)

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