**3. Opinion**

In the past few years, pharmaceutical products have evolved toward disease- and patient-specific therapeutics involving meticulous manufacturing steps. In addition, cellbased therapeutics and vaccines present high sensitivity to environmental and transport conditions, complicating supply chain logistics. Increased drug specificity and demand uncertainty add further complexity to the design and operation of robust manufacturing processes and distribution networks. As Maria M. Papathanasiou et al. [20] discuss in their paper, the pharmaceutical industry has taken significant steps toward improving existing and-or developing novel processes that promise agile, responsive, and reproducible manufacturing. Similarly, distribution networks in the pharmaceutical sector are undergoing a paradigm shift, exploring the capabilities of decentralized models. Such developments accompany digital innovation in the pharmaceutical industry that enables seamless communication between process units, production plants, and distribution nodes. As discussed earlier, process systems engineering has been at the forefront of allowing digitalization through the development of computer modeling tools. The latter can assist with real-time monitoring of critical storage conditions for sensitive pharmaceutical products with short shelf-life, thus increasing drug safety. One of the main challenges hindering the fast exploitation of Industry 4.0 principles in pharmaceutical manufacturing is a mindset change. Practitioners should embrace the benefits arising from the realization of Pharma 4.0 towards replacing paper-based systems with cloud-based servers. That will allow significantly improved agility and productivity in the operations of the pharmaceutical sector.
