Biopharmaceuticals are of substantial value and significance in medicinal treatment. However, their production requires complex processes at a high cost. Through our developments, we apply innovative methods to enable less costly, more reproducible, and safer production. Examples of such technological solutions are inline sensors for real-time monitoring (Process Analytical Technology, PAT), the control of critical process parameters, as well as the development of continuous technologies. Our activities cover the entire biopharmaceutical manufacturing, including upstream, downstream, and formulation processes.
Upstream
Our laboratory deals with mammalian cell cultures in laboratory-scale bioreactors, which are well controllable and can be used as models for the industrial environment. PAT sensors are used for the deeper understanding of complex processes by monitoring critical process parameters. Our advanced control system provides the opportunity to develop feeding strategies, endpoint detection, and ensure the critical quality attributes of the final product.
Downstream
In addition to production processes, we have extensive experience in protein purification and analysis (e.g. monoclonal antibodies). We are developing alternative purification methods, like precipitation or aqueous two-phase extraction, and also working on the improvement of the currently applied industrial chromatographic separations.
Solid formulation
In order to increase the stability of biologics, a continuous gentle drying technology has been developed for the manufacture of a solid formulation of various bioactive agents such as proteins, oligonucleotides, and living cells. The use of pilot-scale, high-speed electrospinning device developed by our group, can provide a suitable technology that is capable of the mass production of sensitive biopharmaceuticals.
Analytical tools
We have a wide range of analytical tools for process monitoring and sample analysis.