Challenge
A major nuclear energy company is developing an innovative project to use an old waste product as an active ingredient in a new targeted cancer therapy. In parallel with the therapeutic development, the company has launched the construction of two manufacturing sites (one in the US, one in France) for the production of future tracers. These facilities will have to meet the requirements of aseptic production and the handling of radioactive products.
Mission
Based on its experience in the field of radiopharmaceuticals, ILS is assisting this industrialist with the French project by carrying out the criticality analysis of the new process and drafting the quality documentation (VMP, URS, System Impact Analysis, DQ, etc.). ILS also advises the project team on the organisation or technical choices impacting the future Pharmaceutical Establishment.
