Lead-time and risk reduction assessment of a sterile drug product manufacturing line using simulation

Digital Twins are finding their way into more and more parts of supply chains. Especially in highly regulated manufacturing processes of the pharmaceutical industry, they are becoming an increasingly valuable tool for improving processes without inducing prolonged downtimes, e.g. through virtual tests and virtual scenario analyses. Simulation can serve as a powerful foundation for digital twins, as it e. g. allows for probabilistic assessments and multi-dimensional optimization of highly complex and dynamic processes. In this study, a simulation model is developed as part of the EU research and innovation programme Horizon 2020. The goal is to explore the benefits of a simulation-based approach and quantify the potential for later adoption in a scalable Digital Twin system. The model is applied as a case study on a sterile drug product manufacturing line of the Roche Diagnostics GmbH in Mannheim, Germany. With the model, sensitivity analyses of process steps, campaign building and batch change scenarios, different shift models, scheduling approaches and delivery breakdown risk assessments were conducted. Results underlined the benefits of simulation-based analyses and the potential for adoption of digital twin technologies in the pharmaceutical industry. (c) 2021 Elsevier Ltd. All rights reserved.