The rise of generic drugs, the pressure on prices and the gradual emergence of personalised medicine have long been challenging the traditional ways of working in the Pharma sector. The Factory 4.0 paradigm, where IT-OT systems are vertically integrated and machines are connected to a cloud platform via IIoT, allowing data collection and analysis in real time with advanced Machine Learning algorithms, represents a powerful vision. The push towards the Smart Factory model, through the introduction of digital enabling technologies, is consequently very strong. That is a new model that will enable a revolutionary approach to efficiency, flexibility, quality, innovation and cost control.
The trend is now established, and it is no coincidence that, according to a multi-sector study by Cordence Worldwide, the priorities of CEOs and CFOs for the post-pandemic era include digitalisation at the top of the list in all business areas. Pharma companies are certainly no exception in this landscape.
To strengthen the point, it is the regulatory authorities themselves who emphasise the opportunities represented by the digitalisation of production processes. In this regard it is of particular significance an FDA statement from 20201 according to which: “Americans may be surprised to learn that many 21st century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an emergency, and contribute to the high cost of medical products. For the past several years, the U.S. Food and Drug Administration has sought to encourage and facilitate the adoption of Advanced Manufacturing which refers to new and emerging approaches for the production of medical technologies”.