Towards Individualized Medicine. Embracing Digital Twins and Digital Dependability in Pharma 4.0

The pharmaceutical manufacturing industry is undergoing a transformative shift towards decentralization and modularization, significantly enhanced by the implementation of digital twins, automated manufacturing, and digital reliability. These technologies improve flexibility, efficiency, and quality assurance by creating virtual replicas of devices, processes, and patients, enabling personalized medicine and optimized drug formulation. Standardization initiatives like Asset Administration Shell (AAS) and Fast Healthcare Interoperability Resources (FHIR) ensure seamless integration and interoperability across systems. Digital dependability frameworks, such as the Digital Dependability Identity (DDI), enhance safety and risk management through predictive analytics. This integration of advanced digital technologies promises to revolutionize pharmaceutical manufacturing, fostering innovation and improved patient outcomes. The aim of this article is to highlight the current advancements and significant potential of digital twins in personalized medicine, and to encourage exploration of new challenges in this field.