Roundtable - Accelerating the development of robust bioprocesses by means of artificial intelligence and in silico models: The next level in the QbD strategy

Like in many other industries, bioprocesses should now be developed by means of computer-based mathematical and stochastic models. This will allow to accelerate the development of bioprocesses and ensure their long-term robustness as well quality products for the patients. There is a growing number of academic and industry projects that aim at using artificial intelligence, big data analysis, mathematical models delivering predictive tools from the bioreactor to the patient. Having such a strategy for developing models on all aspects from the bioreactor to the end of shelf life present tremendous opportunities since it likely will accelerate the development and optimization of new bioprocesses by leveraging predictive analytics outcomes to support decision-making. 

We’ll discuss about the opportunities to enter into the “computer-based biological product development” area, but we also mention the various technical challenges such a vision may induce. 

The central idea is to show how such a trend brings the Quality By Design (ICH-Q8) strategy to the next level and embrace the Pharmaceutical Quality System (ICH-Q10).

Speaker: Bruno Boulanger, PhD, Global Head Statistics and Data Science - Pharmalex