The JDMI Radiopharmacy manufactures, tests and packages radioactive pharmaceuticals used in Nuclear Medicine studies. Our facility holds a Drug Establishment License from
Health Canada and our products are manufactured according to
good manufacturing practices (GMP).
Some of our services provided on both a routine and emergency basis include:
- High quality radiopharmaceuticals (bulk or unit dose)
- Blood cells radiolabeling services
- Radiolabeling of compounds for clinical trials
Contact
For more information about us please contact our radiopharmacist:
Email:
radiopharmacy@uhn.ca
Phone: 416 340 4800 ext. 3672
Fax: 416 340 5065
What are Radiopharmaceuticals?
A Radiopharmaceutical is a radioactive compound administered to the patient, and monitored via specific imaging devices, for diagnosis and therapeutic purposes. It is composed of a radioisotope bond, in most cases, to an organic molecule. The organic molecule conveys the radioisotope to specific organs, tissues or cells. The radioisotope is selected for its radiation emitting properties.
Radioisotopes emitting penetrating gamma rays are used for diagnostic (imaging) where the radiation has to escape the body before being detected by a specific device (SPECT/PET cameras). Typically, the radiation emitted by isotope used for imaging vanishes completely after 1 day through radioactive decay and normal body excretion. The most common isotopes for imaging are: Tc-99m, I-123, I-131, Tl-201, In-111 and F-18.
Radioisotopes emitting short range particles (alpha or beta) are used for therapy due to their power to lose all their energy over a very short distance, therefore causing a lot of local damage (such as cell destruction). This property is used for therapeutic purposes: cancer cells destruction, pain treatment in palliative care for bone cancer or arthritis. Such isotopes stay longer in the body than imaging ones; this is intentional in order to increase treatment efficiency, but this remains limited to several days.
The most common therapeutic isotopes are: I-131, Y-90, Re-188 and Lu-177.
Manufacturing such radiolabelled molecules requires pharmaceutical industry expertise within the safety constraints of a nuclear facility. Therefore, such a facility must comply with the Good Manufacturing Practices of the pharmaceutical industry while at the same time adhering to the As Low As Reasonably Achievable (ALARA) principle of the nuclear industry, aimed at protecting the workers, the environment and the patient. The largest facilities for producing radiopharmaceuticals are located in Europe and North America. Before being accessible for routine clinical use, the radiopharmaceutical has to demonstrate its harmlessness for the patient and its benefit for the diagnosis, like any classical drug.
This demonstration process is strictly regulated by Health Canada in Canada, Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The typical duration for such a process is 5 to 8 years, from the initial discovery to the availability for the physicians.
