Context and challenges
This client is a major player in the biotechnology sector, particularly in the field of allogeneic treatments in gene and cell therapy.
As part of its development, this client has launched an investment program including the setting up of a production unit for Starting Material RNA (RiboNucleic Acid), plasmid and vector.
This project, carried out in the heart of Paris, has the characteristic of "transforming" existing R&D/pilot facilities into a GMP production unit.
This customer mandated Assystem Care for all the missions of Commissioning, Qualification and Validation of the direct impact systems, within the framework of a service of Project Management Consultancy (in the form of a fixed-price contract with commitment of results).
Qualified Equipment / Systems: HVAC, clean utilities, rooms, autoclaves, isolators, PSM, thermostatically controlled enclosures, biotech production and analytical equipment, environmental monitoring system