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.
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