The Isotope Laboratories has manufactured and distributed radiopharmaceuticals since 1952.
Radiopharmaceuticals are used to image organs and lesions during diagnosis, and to treat different illnesses, such as cancer.
Today the Isotope Laboratories has dedicated laboratories for development, production, packaging and quality control of radiopharmaceuticals. They are the only distributor of radiopharmaceuticals to the Norwegian market. Since 2001 the sector has also been involved in the distribution of radiopharmaceuticals for clinical trials to many parts of the world.
The Isotope Laboratories also manufactures pharmaceuticals that are not yet commercially available. Tailoring of products for the customer, as well as radioactive labeling of peptides, proteins, and other substances for the use in research and clinical studies can be performed at the Isotope Laboratories.
The research reactor at IFE was put into operation already in 1951, and in 1952 the first radioactive preparation for medical use was delivered from the Institute of Atomic energy (IFA, as it was then called). This was only 6 years after the first delivery in the world happened from a research institute in Tennessee, USA. Throughout the next years the production of different radionuclides increased rapidly, and already in 1957 the first pharmacist was hired as Leader of Production at the Isotope Laboratories. What started as the production of radioactive Iodine in 1952 was in 1963 increased to 28 different radioactive isotopes in 50 different preparations.
The nuclear reactor JEEP was put into operation in 1951 thanks to the cooperation between the pioneers Gunnar Randers and Odd Dahl. This project turned out to be extremely important for Norwegian research, and was the basis for the radiopharmaceutical business we now have had in Norway for almost 70 years.
In the 80s there were very few patents in the radiopharmaceutical field, and the whole field was very poorly regulated. This led to a leap in the cooperation between universities, international specialists and research centers. Norway now had access to new radiopharmaceuticals, and this led to the Norwegian hospitals being in the frontier of radiopharmaceutical evolution.
Laboratory facilities at IFE in 1965- and in the 1990s
The Isotope Laboratories has dedicated facilities for production, packaging and quality control of radioactive pharmaceuticals. The laboratories are classified both in regard to cleanliness with respect to international GMP-regulations (Good Manufacturing Practice), and to radiation protection.
The Isotope Laboratories has for many years cooperated with Bayer AS (former Algeta) on product development, expansion, and the building of dedicated premises for the contract manufacturing of Xofigo. Xofigo is a radiopharmaceutical based on the radioisotope Ra-223, and is used for treatment of prostate cancer patients with bone metastasis. The product was approved by FDA in the US in May 2013, in Europe in November 2013 and the Isotope Laboratories has since 2013 manufactured Xofigo on a regular basis.
The manufacture of Xofigo has created many new jobs at the Isotope Laboratories, now consisting of seven departments.
What can we offer?
- Contract research and development
- Contract manufacturing
- Chemical analysis
- Microbiological analysis
- Teaching and consultancy
Today the Isotope Laboratories is the only distributor in Norway for radiopharmaceuticals to the Norwegian market. The Isotope Laboratories works as a centralized radiopharmacy for Norway, and controls and distributes all radiopharmaceuticals directly to the nuclear medicine departments at the Norwegian hospitals.
The expertise within distribution of dangerous goods (DGR) and pharmaceuticals (GDP) is essential for handling of clinical trials for our business partners. The Isotope Laboratories has for many years shipped radiopharmaceuticals on a single patient basis worldwide. Import and distribution of short lived radiopharmaceuticals that are not yet produced at the Norwegian PET-centers are also important tasks.
The Isotope Laboratories work with development projects within the radiopharmacy field. The Isotope Laboratories is able to offer small start-up companies production facilities where GMP-rules and radiation protection is ensured.
The Isotope Laboratories has considerable expertise within chemical and microbiological analysis of radiopharmaceuticals. This is used for both contract analysis, and in the development of new products.
The Isotope Laboratories holds several responsibilities within nuclear technology and health. These responsibilities includes statistics of use of radioactive substances to The Norwegian Radiation Protection Authority (NRPA), teaching at university level, as well as consultancy work for Norwegian hospital departments related to the use of radiopharmaceuticals and the design of production facilities and hotcells. The Isotope Laboratories participates in several international committees working to strengthen quality assurance and regulations within nuclear medicine.