title: [(68)Ga-labeled peptides for clinical trials - production according to the German Drug Act: the Göttingen experience].
abstract: The AMG implies far-reaching implications for the synthesis of new radiopharmaceuticals for clinical trials.
  As a part of the DFG-funded Clinical Research Group (KFO 179) a project designated "Immuno-PET for assessment of early response to radiochemotherapy of advanced rectal cancer" was initiated. This trial is focused on a trivalent bispecific humanized monoclonal antibody, and a 68Ga-labeled peptide. Following the new regulatory framework we established a GMP-compliant cleanroom laboratory and applied for a manufacturing permission.
  
  
  RESULTS
  During the project constructural, personnel and organizational conditions for a successful application were established, including a quality management system. A GMP-conform cleanroom laboratory class C was constructed, equipped with a two-chamber lock. The actual manufacturing is performed in a closed system with subsequent sterile filtration. The manufacturing processes have been automatised and validated as well as the necessary quality controls. The manufacturing permission was granted after an official inspection.
  
  
  CONCLUSIONS
  The new German Drug Act is considered as a break in the production practice of nuclear medicine. The early involvement and communication with the authorities avoids time-consuming and costly planning errors. It is much to be hoped that the new legal situation in Germany will not cause serious impairments in the realization of clinical trials in German nuclear medicine.
authors.affiliation: Abteilung für Nuklearmedizin, Universitätsmedizin Göttingen, Germany. birgit.meller@medizin.uni-halle.de
authors.forename: Birgit
authors.initials: B
authors.lastname: Meller
authors.forename: C
authors.initials: C
authors.lastname: Angerstein
authors.forename: T
authors.initials: T
authors.lastname: Liersch
authors.forename: M
authors.initials: M
authors.lastname: Ghadimi
authors.forename: C-O
authors.initials: CO
authors.lastname: Sahlmann
authors.forename: J
authors.initials: J
authors.lastname: Meller
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005710:Gallium Radioisotopes / Q000592:standards* / Q000627:therapeutic use*; D005858:Germany; D010455:Peptides / Q000592:standards* / Q000627:therapeutic use*
chemical_list: D005710:Gallium Radioisotopes; D010455:Peptides