Big data in biopharmaceutical process development vice or virtue

Digitalization is one of the most pronounced trends in our society. In manufacturing, this trend is closely linked to so-called Industry 4.0, which aims to create synergetic connections among all relevant data sources, devices and stakeholders. While industries like automotive have adapted and realized many of the associated prerequisites in its production sites and products, the chemical and particularly the biotechnological and pharmaceutical industry are clearly lagging behind. These conservative industries produce a variety of molecules through complex processes based on a long-standing technological expertise. However; the innovative potential offered by digitalization is vastly unexplored with a digitalization degree recently estimated as 27%1. This article critically addresses the role of big data and big data analytics in the bioprocessing domain, where, for the moment, many data sources remain unexplored, data analysis is often performed in a basic and non-reflected way and data-related decisions are managed in an inefficient and economically non-optimal procedure.