Department of Radiopharmaceutical Production
The main focus of the department is the production of radiopharmaceuticals for diagnosis of oncologic and neurologic diseases as well as for cognitive disorders by means of PET. The preferred radioisotopes used are [18F]fluorine (T1/2= 109.8 min) and [11C]carbon (T1/2 = 20.4 min).
Furthermore, 11C- and 18F-radioisotopes for radiochemistry and radiolabeled compounds for pre-clinical research are provided.
The production of PET radiopharmaceuticals is characterized by:
- Generation of radioisotopes by high energy cyclotron TR-FLEX.
- Radiolabeling, purification and dispensing of the PET radiopharmaceuticals under clean room conditions.
- Quality control and release for clinical application.
As all other drugs for human application the production of PET radiopharmaceuticals has to be performed according the guidelines of Good Manufacturing Practice (GMP) in compliance with national regulations and principles (Arzneimittelgesetz AMG, Arzneimittelwirkstoffherstellungs-verordnung AMWHV). Therefore, HZDR is holding a license for manufacturing of drugs (Allgemeine Herstellungserlaubnis nach §13 AMG) since 1997.