Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization
In 2020, the Covid-19 pandemic resulted in a worldwide challenge without an evident solution. Many persons and authorities involved befriended the value of available data and established
expertise to make decisions under time pressure. This omnipresent example is used to illustrate the decision-making procedure in biopharmaceutical manufacturing. This commentary addresses
important challenges and opportunities to support risk management in biomanufacturing through a process-centered digitalization approach combining two vital worlds—formalized engineering
fundamentals and data empowerment through customized machine learning. With many enabling technologies already available and first success stories reported, it will depend on the interaction of
different groups of stakeholders how and when the huge potential of the discussed technologies will be broadly and systematically realized.