Shielded cell for manufacturing of radioactive drugs (Courtesy CIS bio/IBA)
Handling radioactive substances is not that easy and needs specific tools and environment (hospital, labs, patient rooms). However, contrary to all other applications of radioactive material, Nuclear Medicine works only with short half-life radionuclides. In other words this means that the radioactivity of the injected substances totally disappears in a range of 2 days most of the times, and a maximum of a few weeks. This has a big advantage for patients and hospitals, but a major drawback for manufacturers. As soon as the drug is produced it must be supplied and injected to the patient as fast as possible, as the pharmacological activity of the drug vanishes at the same pace. Industry has developed those specific and complex environments in which these pharmaceutical tools can be handled in full safety. Radionuclides are produced in specific nuclear reactors and cyclotrons and the final radiopharmaceuticals are generated in what can be considered today as the most complex pharmaceutical process. Distribution networks up to the final customer at the hospital are now also fully elaborated and under total control. Beside all these constraints related to their production and delivery, all these radioactive drugs must fulfill all the requirements of both pharmaceutical and nuclear safety authorities before being authorized. Radiopharmaceutical’s authorization undergo the very same process when compared to any other conventional drug before it is placed on the market.
