General Methodology in Bioprocess Engineering

Commercialization of biotechnologies not only depends on intelligent products for the market but also on a rapid and secure methodology for bioprocess design & development. The “old” empirical way of trial & error is to be replaced by a more systematic procedure according to a recent methodology in bioprocess technology, called the “formal macroapproach”, based on a holistic mode of thinking, operating with interaction-networks (integration of biological and physical phenomena). It is based on macroscopic process variables and on formal analogies adapted to experiments, which are used for mathematical modeling. A better scale-up is achieved by a scale-down approach, where regime analysis is used to determine the process bottlenecks, which then are experimentally simulated in the scale-down “model-bioreactors”, representing the new integrating strategy. Mathematical modeling plays a central role representing a simplified but adequate approximation to real process behaviour.