Abstract
Whilst radiopharmaceuticals have an important role to play in both imaging and treatment of patients, most notably cancer patients, nuclear medicine and radiopharmacy are currently facing challenges to create innovative new drugs. Traditional radiopharmaceutical manufacture can be considered as either a routine hospital production or a large-scale industrial production. The gap between these two practices has meant that there is an inability to supply innovative radiopharmaceuticals for use at the local level for mono- or multicentric clinical trials with satisfactory quality and safety specifications. This article highlights the regulatory requirements in aseptic pharmaceutical processing and in nuclear medicine to be able to locally produce radiopharmaceuticals. We validate the proof-of-concept for an “in-house” hospital-based radiopharmacy including an on-site cyclotron, that can fulfill the conflicting requirements between radiation safety and aseptic processing. The ARRONAX in-house radiopharmacy is currently able to provide sterile and pyrogenic-free injectable radiopharmaceutical compounds for both industrial and institutional clinical trials.
Highlights
Nuclear medicine is a medical specialty that uses radioactive atoms for diagnosis and/or therapy
The variety of available radioisotopes for radiopharmaceutical use was quite limited; recent progress in radioisotope production and in the development of new vector molecules has changed the field of nuclear medicine considerably
French regulation is directly under the control of international legislation adopted by the European Medicines Agency (EMA) including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICHQ7 Good Manufacturing Practice for Active Pharmaceutical ingredients”) and the World Health Organization Annex 6 (“WHO Good Manufacturing Practices for Sterile Pharmaceutical Products”)
Summary
Nuclear medicine is a medical specialty that uses radioactive atoms for diagnosis and/or therapy. The variety of available radioisotopes for radiopharmaceutical use was quite limited; recent progress in radioisotope production and in the development of new vector molecules has changed the field of nuclear medicine considerably. This is relevant to the management of oncology patients, with a large number and variety of new radiopharmaceuticals reaching the clinical trial stage. To support this increased need, particle accelerators such as cyclotrons were built around the world to produce various radioisotopes. Due to the physical properties of radioisotopes and the transportation regulation constraints, a network of cyclotrons has been created such that the production site is relatively close to the hospital unit where the radiopharmaceutical is injected into the patients
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