UW Radiology

Production Timeline

Contact us for scheduling

  • Scheduling lead times approximate 1-4 weeks, dependent upon radiochemistry facility, cyclotron, and PET scanner availability
  • Radio-tracer is provided in a pre-determined formulation in accordance with human dose regulations

Information and methods transfer

  • All available methods documentation and critical references provided
  • Sources for specific material and reagent needs and established, i.e., standards and precursers
  • Initiate write-up of study application

Establish all protocols in-house

  • Implement synthetic method and obtain in-house production profile for purified product
  • Confirm final formulated dose meets regulatory and set quality control standards
  • Confirm system suitability and complete validation of HPLC analytical assay
  • Carry out stability studies for pre-curser and standards formulation and storage

Finalize SOP documentation and complete qualification runs

  • Complete all written SOPs for synthetic process and quality control assays.
  • Complete qualification runs per regulatory requirements and confirm reproducibility of process and quality control of final bulk radiotracer dose

Submission and approval of study application

  • Continue stability studies per project needs
  • Complete and submit study application

Project Proposal Information Transfer

  • Confirmation of facilities, equipment, and material needs
  • Provide all available methods, and documentation and critical references
  • Source reagents and materials for investigation of synthetic and analytical methods

R&D of synthetic and/or analytical methods

  • Research and development of synthetic method
  • Finalize synthetic method, purification of crude, and formulation of bulk dose; establish reproducibility of process.
  • Confirm removal of organic solvents below USP allowable limits
  • Confirm system suitability and complete validation of HPLC analytical assay
  • Set quality control standards for final bulk radiotracer dose
  • Carry out stability studies for pre-curser and standards formulation and storage
  • Initiate write-up of study application

Finalize SOP documentation and complete qualification runs

  • Complete all written SOPs for synthetic process and quality control assays
  • Complete qualification runs per regulatory requirements and confirm reproducibility of process and quality control of final bulk radiotracer dose

Sumbission and approval of study application

  • Continue stability studies per project needs
  • Complete and submit study application