The IRAB boasts one of the best-equipped facilities in Europe for the development and production of radiopharmaceuticals for different uses and applications.

These cutting-edge facilities, combined with the experience and expertise of the IRAB team, enable it to operate as a fully-integrated contract manufacturing organization capable of offering quality solutions to the pharmaceutical and biotechnological industries.

The new facilities guarantee major productive capacity and flexibility – aspects that are decisive in ensuring a quality service and in guaranteeing reliable, punctual and profitable manufacturing.

Manufacture of radiopharmaceutical products
  • Aseptic process
  • Labeling, inspection and packaging
  • Organic synthesis, purification and formulation
  • Filter-product compatibility studies
  • GMP and radiological protection standards
  • Terminal sterilization
  • Microbiology services
  • Regulatory services
  • Pharmacovigilance
  • Technical transfer of analytical and microbiological methods
  • Method validation
  • High-performance thin layer chromatography
  • Kinetic colorimetry for endotoxin determination (LAL test)
  • Testing of finished products and incoming starting materials
  • Sterility and bioburden testing
  • FID gas chromatography
  • Testing for long half-life impurities
  • Process validation
  • Project plan drafting
  • Generation of protocols and summary reports
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Process qualification (PQ)