Biopharmaceutical proteins are a pillar of our modern healthcare systems. These may include monoclonal antibodies for cancer therapy as well as innovative vaccines with therapeutic effects. The establishment of the necessary production and purification processes is based in part on intransparent empirical values and is often based on a trial-and-error approach. This can result in unpredictable delays in process and product development and ultimately slow down the market launch of the associated product, with corresponding financial drawbacks for the manufacturer. Under such time pressure, not all possible process variants can be tested and a global optimum in terms of yield and costs may not be identified.
The department of Bioprocess Engineering at the Fraunhofer IME in Aachen addresses these challenges through intensive research on model-based process development. On the one hand, the accumulation of products (e.g. recombinant proteins) is predicted based on models that account for the effect of different genetic elements such as promoters and untranslated regions (UTRs). On the other hand, methods are being developed which enable the evaluation of downstream processes with regard to yield and product purity. These methods characterize the separation behavior of proteins during different unit operations (e.g. chromatography) including mass balances. In addition, the department deals with the integration and evaluation of the collected data as well as their utilization for the improvement of the different models.