Project 3 – Quality by design and control

A paradigm shift is underway in the pharmaceutical industry: from static to adaptive processes. Today, the standard procedure to minimize disturbances is to make the operation repeat exactly the same pattern as the ideal operation. The end product is then accepted or rejected based on rigorous analysis after production.

By adopting the idea that disturbances will always be present and that on-line measurement and control can compensate for them during operation, the pharmaceutical industry can gain a production system that is more efficient and more similar to other industries. The controllability becomes an important aspect of the production process.

The project ended in 2013 but the research continued in PiiAbio.

The project Quality by design and control was focused on industrial case studies of protein separations by preparative chromatography. In order to set up the appropriate measurements and controls, the processes must be fully understood. Mathematical modeling is a means to this end and was therefore an important part of the project. A simulation software for preparative chromatography with a general model library was developed.

Further research activities involved application of a model-based methodology to industrial case studies, further development of the simulation software and modeling of related processes such as protein aggregation and the influence of salt and organic solvents on the chromatographic separation.

Download the preparative chromatography software used in this project here.