Continuous Digitalized Processes for Producing Biopharmaceuticals

Introduction

Biopharmaceuticals are essential for the medical treatment of diseases like immune deficiencies, cancer, and diabetes, and provide an indispensable component to the health care system worldwide, as showcased by mRNA vaccines in the recent pandemic. Despite this success, manufacturing is still based on traditional, outdated batch production technologies, and on process development procedures based on historical experience and empiricism leading to many inefficiencies, like very long values of time-to-market.

Need for Modernization

There is an urgent need to introduce modern integrated, continuous, and fully digitalized production processes to also cope with the upcoming cell and gene therapies and the emerging personalized medicine. I develop here revolutionary process development and operation methodologies to enable this.

Digital Twin Approach

These methodologies are based on a Digital Twin, which includes the first continuous, integrated, and fully digitalized plant for producing mRNA. The “engine” consists of innovative hybrid models for each unit of the plant, which are updated in real time through continuous learning techniques. These provide the predictive capabilities needed for:

• Monitoring and control
• Knowledge transfer
• Scenario analysis
• Experimental planning

Development of Hybrid Models

I will develop a new generation of hybrid models and innovative machine learning algorithms and provide the experimental evaluation and validation of my methodologies. Other high precision continuous processes, like flow-chemistry for sustainable catalytic processes or microfluidics for the controlled synthesis of nanomaterials, will benefit from these results.

Expertise and Impact

I am a recognized pioneer in the scientific foundations of continuous operation in biopharma. This inspired me to develop this disruptive Digital-Twin-based methodology and cope with the associated high risk. With about 110 PhD students advised in my career and now active in Academia and Industry, I know how to inspire a new generation of scientists with the novel science emerging from this project.