The Critical Role of Predictive Bioreactor Characterization in Process-based Upscaling

Bioreactor characterization plays a central role in process-based upscaling. New scaling strategies are developed based on standard scaling procedures and a growing database of measured process parameters.

In bioreactors, microorganisms or cell cultures produce complex therapeutic proteins and other biopharmaceuticals. To achieve the optimum conditions, the design of the bioreactor and a sophisticated selection of parameters within the fermentation process is crucial. The goal in the design of the bioreactors used for industrial upstream processing is to maintain similar process conditions to those which apply on a small scale during product development and validation.

This raises the question:

“To what extent is the replication of the environmental conditions of a small-scale lab reactor applicable to that of a large-scale bioreactor of 20,000 liters or more?”