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Project Summary

The rapid development of methodologies in personalised medicine – from cell therapy to patient-specific tested and composed pharmaceuticals – leads to huge potential to revolutionise treatment of a wide range of diseases in the future. To exploit this potential, it is necessary to produce human cells patient-specific in an industrial scale. Nowadays, personalized cell production and cultivation is only executed by manual processing or semi-automated on laboratory scale. This makes the results of cell cultivation highly dependent on human interaction which restricts accuracy, reproducibility, and efficiency of the processes – and, as a result of this – constant quality of the processes is nearly impossible.

In order to overcome these issues and make patient-specific production of cells available for a wide range of applications, ManuCyte focuses on the development of an intelligent, modular manufacturing platform for flexible, patient-specific cell production which will increase efficiency of personalised cell production in terms of quality, throughput, and costs.

This objective will be reached by combining several high-sophisticated technologies such as

  • a modular and scalable concept for the setup of cell production platforms, which is based on plug-ins and allows a flexible composition of functionalities, extension of capacities, as well as fast ramp up.
  • a micro-fluidic component which provides cell culture medium specifically customised for each cell culture.
  • Bioreactors with integrated sensor technology, which are capable for highly automated processes as well as the associated incubation component
  • the application of a cost-neutral cleanroom and sterilisation concept to keep cell cultures free of contaminations from the environment and between different cell cultures. This includes the development of flexible connectors between the fluidic component and bioreactors which have to fulfil sterility requirements.
  • optical and biochemical inline monitoring methodologies, which enable the evaluation of cell status within the production process
  • a MES (Manufacturing Execution System) with LIMS (Laboratory Information and Management System) functionalities for the control of the automation platform, which includes a self-learning knowledge-based cell behaviour model and advanced cell process control functionalities for self-optimization of cell production processes.

To enable an efficient application of all these technologies and approaches, the project consortium consists of SMEs and research institutes that are very specialised on their field of activity, such as liquid handling, cell imaging, cell culturing, software development, and automation. This also represents the project’s basic principle which states that only the close cooperation between organisations from different branches and – as a result – combination of technologies can lead to a successful execution of such a multi-focussing project.