White Paper: The Critical Role of Predictive Bioreactor Characterization in Pharmaceutical Process-based Upscaling
New scaling strategies are developed
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.
Bioreactors used for industrial upstream processing
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?”
Find out more about this crucial question in ZETAs most recent white paper about bioreactor characterization!
Thorough bioreactor characterization leads to insights beneficial for scaling and makes it easier to prove regulatory requirements.
Portfolio Manager Business Line Customised Systems
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