(71d) Design and Application of Scale-down Models in Cell Culture Processes

The commercial use of cell culture processes at scales up to 25m³ for the production of post-translationally modified proteins using recombinant DNA techniques has made cell culture a cornerstone of modern biotechnology. The scale-up of cell culture processes developed in the laboratory often presents problems, which owing to the complexity of multiple parameters, many of which are cell line specific, do not permit a generalised solution. Scale-up issues can also arise when an existing process is subjected to modifications (e.g., medium or cell line improvements). The most important requirement for experiments on the small scale is that they have to be representative of the conditions at the large scale. This obviously determines the possibilities and limits of the scale-down approach.

This presentation will focus on the concept and practical design of lab scale models and will highlight the usefulness of such models for scale-up and trouble-shooting as well as process characterization and validation of cell culture processes. Examples of miniaturized (sub mL) scale down models will also be discussed.