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, the radioisotopes 64Cu, 131Ba and 197mHg are provided for radiochemistry and pre-clinical research.
The production of PET radiopharmaceuticals is characterized by:
- Generation of radioisotopes by high energy cyclotron TR-FLEX.
- Radiolabeling and dispensing of 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 GMP certificate and a license for manufacturing of drugs (Allgemeine Herstellungserlaubnis nach §13 AMG).