Soft Sensors for In-line Real-Time Monitoring of Critical Quality Attributes in Bioproduction

Purpose and goal

The aim of the project was to develop new technology to enable real-time monitoring of biomolecules during the production of biological drugs. The aim was to create better conditions for intensification and automation and thus be able to reduce the costs for development and production of these expensive but important products. In line with the set goals, we have developed unique sensor systems that can provide information on product concentration and product quality in real time in various process steps. The technology has been evaluated industrially with good results.

Expected results and effects

We have developed and evaluated robust sensor systems that can specifically measure concentration of monoclonal antibodies in real time. The sensors have been optimized and tested in different process steps, both downstream and upstream, and in different scales for process development and production up to pilot scale. Through the development and implementation of machine learning algorithms, aggregate concentration information can also be obtained. Sensor systems can make it faster, easier and cheaper to develop and produce biological drugs.

Planned approach and implementation

The project involved two academic research groups as well as four different companies. The project parties met regularly for evaluation of results and planning of the work. Much of the work was carried out in various smaller constellations as needed, which created flexibility and facilitated decision-making. Some parts of the project turned out to be more complicated than expected, but the work generated a lot of new knowledge that will be useful in further work with project partners. Other parts of the work went faster than planned and resulted in the development of new products.