GMP-compliant syntheses of PET tracers for clinical use

GMP-compliant syntheses of PET tracers for clinical use

Background

One essential aim of the dkfz is the translation of basic into clinical research. To fulfil the translation of new PET tracers into clinical application, special laboratory environments are needed to set up Good Manufacturing Practice (GMP)-compliant (fully) automated radiosyntheses which are performed in highly sophisticated clean rooms that comply with radiation.

Production
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Dispensing
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Quality Control
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Past and ongoing projects and significant accomplishments

For the GMP-compliant syntheses of F-18-FDG, F-18-FET, F-18-FLT and Na-F-18F the Division of Radiopharmaceutical Chemistry possesses a manufacturing license and is therefore allowed to produce these tracers for human applications. The PET tracers are produced by fully automated radiosyntheses under clean room environment which comply with radiation protection as well as with the EU-GMP regulations for radiopharmaceuticals. The obtained injection solutions are sterile filtered before their application. To be released for use by a qualified person, the product has to fulfil strict quality criteria. The parametric quality control has to comply with GMP regulations and orients towards the current European Pharmacopoeia. The GMP-compliant productions of PET tracers are conducted on a daily basis. In average between 600 and 700 batches of PET tracers per anno are released by a qualified person of the Division Radiopharmaceutical Chemistry.

The preparation of applications for manufacturing authorization for two Ga-68-labeled peptidic tracers, namely Ga-68-PSMA-HBED-CC and Ga-68-DOTATOC, are ongoing. Ga-68-PSMA-HBED-CC was developed in our division and holds great promise as a specific PET tracer for the imaging of PSMA in prostate cancer. Ga-68-DOTATOC is a routinely used tracer for the imaging of somatostatin receptors. When produced under the pharmaceuticals act, both tracers can be used in prospective clinical studies to further verify their clinical potential.

Future directions

The rooms for the GMP-compliant production of PET tracers at dkfz are at the moment very constricted. When the division moves to a new GMP production site, further tracers will be produced for clinical use in humans, e.g. F-18-FMISO, F-18-FDOPA, and others.

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