The Industry 4.0 concept refers to automation and data exchange in manufacturing technologies, which includes technologies for cell therapy product manufacturing. An important aspect of this concept is the development and use of Digital Twins. A Digital Twin is a digital representation of a product or process that is used to optimize the design and use of said product or process. In this opinion article, we show that such Digital Twins have already been developed for a variety of tissue engineering processes. Using skeletal tissue engineering as a case study, we discuss a number of models at various stages of use between bench and bedside and ranging from pure data-driven models to models built on known mechanisms and first principles. Finally, we emphasize the importance of data collection and model validation to ensure, amongst others, compliance to regulatory guidelines.
Full Access Link: Current Opinion in Biomedical Engineering