Thibault HELLEPUTTE

The production of ATMPs is destined to be decentralised, i.e. via multiple local production units, rather than centralised, as is the case for most traditional treatments, in order to meet a number of challenges, such as personalisation, accessibility, cost reduction and rationalisation of transport. However, this decentralised production brings with it a number of challenges. Data consolidation is difficult and sometimes impossible, if local production units are operated by different companies. Monitoring production is also more complex, because each production site generates fewer batches (statistical difficulties). A larger number of installations makes fault detection and maintenance more complex. Regular improvements to production processes are also made more difficult. The aim of the project is to respond to these challenges by developing innovative digital tools that will enable decentralised ATMP suppliers to be more competitive by exploiting as much data as possible from local production units in order to bring added value to the users of these production units, while preserving the required confidentiality.
Orgenesis Services will generate and make production data on different equipment available.. The company will take the opportunity provided by the project to integrate an OMPUL at Marche-en-Famenne. In particular, the data will illustrate autologous cell therapies. The data produced on different equipment will feed different databases, which will then be used by UCLouvain and DNAlytics to develop collaborative AI models based on federated learning to be able to use all the units’ data securely and reinforcement learning to optimise the operation of each unit. These innovations will then be integrated into DNAlytics’ Hercule software suite which is already in place in a number of biotech companies, but has so far been used for centralised production processes.
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