The positron emission tomography (PET) landscape is rapidly changing and, in the last decade, &gt;10 new PET radiopharmaceuticals have received FDA approval including a number of imaging agents with theranostic applications. At the same time, research use of PET to support drug discovery is rapidly expanding. This is creating an unprecedented demand for PET imaging which is beginning to stress exisiting infrastructure and present new challenges for PET drug manufacturers. Radiochemists need to produce larger numbers of more diverse radiotracers laebeld with different radionuclides each day (e.g. 11C, 18F, 64Cu, 68Ga) for clinical use at the same time as they are asked to label more complex chemical space (e.g. proprietary pharmaceutical assets, new imaging targets, and radiopharmaceutical discovery). At the same time, cGMP is increasing the regulatory burden, complexity and cost of PET drug manufacturing. Addressing these challenges needs fundamental new approaches and technology for conducting PET radiochemistry and our group is motivated to simplify the design, syntheses and quality control of PET radiopharmaceuticals. This presentation will describe a mutlipronged approach to meeting todays radiopharmaceutical production demands including translation of the latest cyclotron targets for production of high demand radionuclides like 68Ga, new approaches to radiochemistry automation, radiochemistry methodology allowing new chemcial space to be radiolabeled (e.g. late-stage radiofluorination), approaches for streamlined quality assurance and regulatory compliance, and application of machine learning and artificial intelligence to radiochemistry in order to streamline the design and synthesis of new PET drugs. The latest developments in each of these priority areas will be described.

New strategies for radiolabeling bioactive molecules with positron-emitting radionuclides

ACS Spring 2022

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