On the wave of more and more manufacturers embracing the pervasive mission to build digital twins, also biopharmaceutical industry envisions a significant paradigm shift of digitalisation towards an intelligent factory where bioprocesses continuously learn from data to optimise and control productivity. While extensive efforts are made to build and combine the best mechanistic and data-driven models, there has not been a complete digital twin application in pharma. One of the main reasons is that production deployment becomes more complex regarding the possible impact such digital technologies could have on vaccine products and ultimately on patients. To address current technical challenges and fill regulatory gaps, this paper explores some best practices for TwinOps in biomanufacturing – from experiment to GxP validation – and discusses approaches to oversight and compliance that could work with these best practices towards building bioprocess digital twins at scale.

Please read our whole pre-print here: https://doi.org/10.36227/techrxiv.16478856.v1