Innovative soft sensors for in-line monitoring of animal cell culture processes – ProCell-In-line

Processes of mammalian cell culture have become essential for the production of recombinant therapeutic proteins since more than 70% of the monoclonal antibodies for therapeutic use are produced by CHO cells (Chinese Hamster Ovary). As a result, the PAT (Process Analytical Technology) approach developed jointly by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recommends the use of on-line characterizations to control production processes and ensure the quality of the finished product in terms of safety and efficacy. In this context, Near-Infrared spectroscopy (NIR), Raman spectroscopy or dielectric spectroscopy have gained interest in recent years as tools for in-line monitoring of bioprocesses. However, in-line monitoring of these processes remains assured by simple methods which do not reflect the complexity of the biological catalyst. The challenge of ProCell-In-line project is to offer an innovative and enriched approach for in-line monitoring of producing monoclonal antibodies processes, in particular the evolution in real time of the functional characteristics of animal cells and of the quality (glycosylation) of the antibodies, in order to monitor animal cells behaviour in real time, for improving the implementation and performance of these processes. The project proposes a combined experimental and methodological approach to develop scientific knowledges that will be based on a multidisciplinary approach including: process engineering, spectroscopic methods (Raman, NIR, dielectric), multivariate analysis of spectral data and process control.