Modular 01 project consists of the development of a new generation synthesizer dedicated to the production of radiopharmaceuticals used as diagnostic (tracers) or therapies.
The system is made of different sub-modules for the radioisotope management, the labeling step, the post labeling chemistries and the final purification / formulation. These sub modules can be used independently, all together or in combination, and have the self-clean up capability. Improvement of dead volumes, resistance to radioactivity, size of the reactor, chemical sampling, chemical and radioactive waste management as well as the reaction parameters optimization are required improvements to shorten the drug development time. The validation of the system in pharmaceutical production, and its production under the ISO13485 medical device standard, will enable the machine to be provided with all the necessary documentation, so that the pharmaceutical files are created much faster for submission to the authorities.
The device will improve the compounds screening in R&D laboratories and their transfer to pharmaceutical production. It will also be weaned off his dependence on proprietary consumable, today’s major bottle neck of radiopharmaceutical drug development.
Consortium
Companies : OOC / ORA (Out and Out Chemistry / Optimized Radiochemical Applications), NUCLEIS
Universities : ULiège, UNamur
Contact
Vincent Tadino: vtadino@oandoc.com
Website: http://www.neptis-vsa.com/
