Dr. Torsten Knieß

Head Production of Radio­pharma­ceuticals
Targetry, Target Chemistry and Radiopharmacy
Phone: +49 351 260 2760

Dr. Martin Kreller

Head Targetry, Target Chemistry and Radiopharmacy
Phone: +49 351 260 4029

HZDR is holding marketing authorizations for following PET radiopharmaceuticals

  • [18F]FDG ([18F]fluoro-2-deoxy-D-glucose) - GlucoRos© since 2005
    [approval No. 63584.00.00]
  • [18F]Sodium fluoride for injection - NaFRos© since 2012
    [approval No. 79232.00.00]
  • [18F]FDOPA (3,4-dihydroxy-6-18F-fluoro-L-phenylalanine) – DOPARos© since 2017
    [approval No 87703.00.00]

Disposal and shipment of GlucoRos©, NaFRos© and DOPARos© is performed by our partner ROTOP Pharmaka GmbH.

The following PET radiopharmaceuticals were produced in frame of our manufacturing license for in house application

  • [11C]Methionin (for investigation of brain tumors and amino acid transporters)
  • [18F]FMISO ([18F]Fluoromisonidazole for evaluation of tumor hypoxia)
  • [18F]PSMA-1007 (a new radiotracer for prostate cancer imaging)

Additionally, HZDR is approved by GE Healthcare as manufacturing facility of

  • [18F]Flutemetamol (Vizamyl©), a radiotracer used for estimation of ß-amyloid neuritic plaque density in human brain.

Further PET radiopharmaceuticals and radioisotopes can be provided for pre-clinical research on request

  • [18F]FLT ([18F]fluorothymidine)
  • [18F]FET ([18F]fluoroethyltyrosine)
  • [18F]Fluoride for radiolabelling
  • [64Cu]Cu for radiolabelling

Quality control

Each single batch of our produced radiopharmaceuticals is daily analyzed by quality control for the following parameters before release for clinical application:

  • identity
  [HPLC, half-life, γ-spectrometry]
  • radiochemical purity
  [radio-HPLC, radio-TLC]
  • chemical purity
(by-products /starting materials) [HPLC, TLC]
  (residual solvents) [GC/MS]
  • radionuclidic purity
  [half-life, γ-spectrometry]
  • pH-value
  • osmolarity
  • microbiological purity
(bacterial endotoxins) [LAL test]
  (sterility) [sterile test for sample A and B]
  • in process controls during production
  [particle, microbiology, humidity, temperature]
  • hygiene
  [personnel, rooms, equipment]