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Automation of a Positron-emission Tomography PET Radiotracer Synthesis Protocol for Clinical Production
Published on: October 26, 2018
To be GMP or not to be- a radionuclide's question
Clemens Decristoforo1, Renata Mikolajczak2, Clive Naidoo3
1Department of Nuclear Medicine, Medical University Innsbruck, Anichstrasse 35, Innsbruck, A-6020, Austria. Clemens.Decristoforo@i-med.ac.at.
Background:
Radionuclides are the essential component of radiopharmaceuticals, their production needs to consider pharmaceutical regulations and guidelines, also for clinical research applications.
Main Body:
In this paper we reflect on the pharmaceutical regulatory landscape for radionuclide production in Europe, with a focus on Good Manufacturing Practices (GMP). The challenges for novel production pathways and the pathways for non-GMP production of radionuclides are discussed.
Conclusion:
In particular when radionuclides are used as starting materials, exemptions from GMP requirements are essential for clinical innovation and a common understanding is needed to enable the safe use of novel radionuclides for medical applications without unnecessary regulatory hurdles for the user.
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