Radiopharmaceuticals are used in the specialised area of nuclear medicine (clinical imaging and therapy) to diagnose, evaluate and treat diseases.
The use of radiopharmaceuticals covers a broad range of procedures such as:
- diagnosis (single photon emission computed tomography, SPECT; and positron emission tomography, PET)
- radiation therapy (for oncology and palliative pain management)
- early research and clinical development employing radio-labelled molecules (e.g. pharmacokinetics, metabolism, receptor-binding studies)
Radiopharmaceuticals are characterized by the fact that they contain one or more radioactive isotopes which decay spontaneously under emission of ionizing radiation. From a pharmaceutical point of view, most ready-to-use radiopharmaceuticals are presented in the pharmaceutical form of solution for injection. However, there are a few products available as oral dosage forms (tablet, capsules), colloidal suspensions and even as radio-labelled patient’s autologous cells.
Treatments with radiopharmaceutical therapy aren’t new, radionuclides to target cancer cells via antibodies or other conjugates have been in clinical trials for well over twenty years, however this treatment area continues to present challenges. Beyond the complexity of country-by-country regulatory requirements, radiopharmaceuticals cannot be thought about in the same way as traditional medicines. For a patient enrolled in a radiopharmaceutical clinical trial, they are being administered a product which has a very short half-life that may quickly start to decay and become potentially inert, thus hampering it usefulness to the patient and the clinical trial.
Cooperation and coordination is essential during clinical trial set up and every step thereafter; from the facilities and procedures where the radiopharmaceutical is manufactured, to its handling and storage, QP certification and release, all the way to the transportation of the drug to the clinical site and administration to the patient. In extreme cases, clinical sites may need to be chosen due to their proximity to the manufacturing site, with transport plans & timelines showing the maximum distance between the two locations.
Unlike traditional clinical trials where supplies are manufactured and packaged sometime month or years in advance of patient visits, for radiopharmaceuticals it is not uncommon to have the manufacturing processes flipped and be scheduled to meet the specific patient visit. This is to allow for the very short half-life when shipping ‘hot’ products. As a result, the production, QP certification and release in the EU and transport to the site need to be coordinated with absolute precision in order to meet the date & time of the patient visit.
With regards to set up of your radiopharmaceutical clinical trial, stringent regulatory guidelines, above and beyond the normal processes have the possibility of hampering or delaying your anticipated starting timelines. Having a partner like MIAS that understands the regulations, not just in one country but many, is imperative. In every single EU member state there is national legislation on medicinal products referring to EU directives, and in some instances, to regulations issued by the national competent authorities. Despite their shared references to the relevant EU directives, national regulations are not always equivalent to each other with regards to radiopharmaceuticals and other GMP processes.
In addition, transportation across borders needs to happen in accordance with the International Air Transport Regulations (IATA) Dangerous Goods Regulations or other applicable legislation for alternative modes of transport. This will govern how the radiopharmaceuticals supplies should be packaged and labelled for transport depending on the type and activity of the material being transported.
How MIAS Pharma can help?
MIAS Pharma is a QP batch certification site with expertise in radiopharmaceuticals. We partner with our clients to provide solutions for batch release of clinical trials into the EU and rest of the world.
For any questions get in touch with us at info@miaspharma.com