Radiopharmacy Core Facility (RCF) - our offer

Novel radiotracers produced by RCF can be broadly applied for imaging research, for example in oncology, psychiatry, neurodegeneration, inflammation, and cardiovascular diseases. RCF provides PET radiotracers for pre-clinical and clinical research. Requests for synthesis of other radiotracers or other radiolabelling services can be sent to us.

The radioligans produced by RCF-KI are used in PET for investigations of physiological and pathological processes, mainly in clinical neuroscience, as well as to study pharmacokinetic properties of novel radioligands developed by research groups as part of academic or contract research in collaboration with pharmaceutical industries.

Novel pharmaceuticals developed by pharmaceutical industry collaborators are also evaluated with PET, either through direct radiolabelling of the drug, to assess e.g. brain exposure, or through evaluation of their pharmacodynamic and pharmacokinetic properties through PET receptor occupancy studies. RCF-KI can provide researchers interested in pre-clinical and clinical studies with radioligands of interest.

The novel radiotracers validated and produced by RCF-KI can be broadly applied for imaging research, for example in psychiatry, neurodegeneration, oncology, inflammation, and cardiovascular diseases.

Services

Radiopharmaceutical development and preclinical set-up

The development of new radiolabelling strategies and radiotracers for preclinical studies is done by the Halldin/Farde research group.

The Halldin/Farde research group (https://ki.se/en/cns/lars-fardechrister-halldin-research-group) counts with 40 years of experience in radiochemical development. Shared equipment and expertise between RCF-KI and the Farde/Halldin research group provide a unique opportunity for the development and pre-clinical evaluation of new radiotracers. Our state-of-the-art laboratory is equipped with two cyclotrons for the production of various short-lived radioisotopes (oxygen-15, carbon-11, fluorine-18, gallium-68) and automated and semi-automated synthesis modules enable various labelling strategies.

  • 18F-Fluorination 
  • 11C-Methylation
  • 11C-Carbonylation
  • 11C-Carboxylation
  • 68Ga-complexation

If you are interested in the radiopharmaceutical development and pre-clinical set-up, please contact Christer Halldin (christer.halldin@ki.se) for an initial project evaluation.

Pre-clinical production

The new radiotracers developed by the Halldin/Farde research group are produced by RCF-KI for pre-clinical studies.

RCF-KI performs the production and quality control of radiotracers for preclinical studies in a clean-room laboratory (class D air quality) that ensures high radiotracer quality.

TracerMakerTM

Fully automated computer-controlled radiochemistry systems intended for carbon 11 and fluorine-18 labelling:

  • [11C]CH4 cryogenic trapping
  • [11C]CH4 transformation into [11C]CH3I
  • [11C]CH3I transformation into [11C]CH3OTf
  • 11C-Methylation reaction (-80 – 200 °C)
  • [11C]CO2 cryogenic trapping
  • [11C]CO2 reduction into [11C]CO
  • 11C-Carboxylation/Carbonylation reaction (-80 – 200 °C)
  • [18F]F- trapping and drying
  • [18F]F- elution and re-processing
  • 18F-Fluorination reaction (-80 – 200 °C)
  • Semipreparative HPLC purification
  • Formulation
  • Sterilization

FIA

A semi-automated radiochemistry system intended for fluorine-18 and gallium-68 labelling:

  • [18F]F- trapping and drying
  • [18F]F- elution and re-processing
  • 18F-Fluorination reaction (-80 – 200 °C)
  • 68Ga-Complexation (-80 – 200 °C)
  • Semipreparative HPLC purification
  • Formulation
  • Sterilization

Radiochemical and chemical purity analysis including molar activity determination, and pH measurement are integrated quality control parameters for pre-clinical productions.

Clinical set-up and production

RCF-KI works in a fully GMP-compliant class C laboratory for the set-up and production of radiotracers for clinical studies.

The set-up, production and quality control take place in qualified equipment according to EudraLex Volume 4 – Good Manufacturing Practice (GMP) guidelines governing the production of medicinal products in the European Union. Our operations are overseen by a Quality Assurance function that ensures that our products are compliant with the current regulations.

In connection with the set-up and validation activities, we offer CMC compilation services for the submission of your (n)IMPD to the regulatory authorities.

Our clinical production and quality control processes are validated according to EudraLex Volume 4 to ensure that our radiotracers achieve the highest quality standards.

11C-Methylation TracerMakerTM

A fully automated and GMP compliant radiochemistry system dedicated to methylation reactions:

  • [11C]CH4 cryogenic trapping
  • [11C]CH4 transformation into [11C]CH3I
  • [11C]CH3I transformation into [11C]CH3OTf
  • 11C-Methylation reaction (-80 – 200 °C)
  • Semipreparative HPLC purification
  • Formulation
  • Sterilization

11C-Carboxylation/Carbonylation TracerMakerTM

A fully automated and GMP compliant radiochemistry system dedicated to carboxylation and carbonylation reactions:

[11C]CO2 cryogenic trapping. 
[11C]CO2 reduction into [11C]CO. 
11C-Carboxylation/Carbonylation reaction (-80 – 200 °C)
Semipreparative HPLC purification.
Formulation.
Sterilization

18F-Fluorination TracerMakerTM

A fully automated and GMP compliant radiochemistry system dedicated to fluorination reactions:

  • [18F]F- trapping and drying
  • [18F]F- elution and re-processing
  • 18F-Fluorination reaction (-80 – 200 °C)
  • Semipreparative HPLC purification
  • Formulation
  • Sterilization

The radiotracers produced for clinical studies are subjected to a strict quality control procedure that ensures subject safety. The quality control parameters depend on the production process but typically encompass:

  • Radiochemical purity by HPLC
  • Radiochemical purity by TLC
  • Chemical purity by HPLC
  • pH
  • Sterile filter integrity
  • Residual solvents
  • Residual metals
  • Bacterial endotoxins
  • Sterility
  • Radionuclidic identity
  • Half-life
  • Shelf-life

Radiometabolite analysis

Radiometabolite analysis, activity measurement in blood and plasma analysis is an essential part of PET studies to understand the behavior of the radiotracer in the body.

We also offer the collection of plasma PK samples and protein binding analysis on blood and plasma, which is an important parameter in the development of new radiotracers.
 

Rates

RCF-KI welcomes both academic and industrial projects. If you are interested in the services offered by RCF and for price information, please contact Thuy Tran and Christer Halldin for an initial project evaluation and for price settings.