GMP-compliant syntheses of PET tracers for clinical use

Background

One essential aim of 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, highly sophisticated clean rooms are essential that comply with radiation protection.

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 [18F]FDG, [18F]FET, [18F]FLT, Na[18F]F as well as 68Ga-PSMA-11 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 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 is oriented towards the current European Pharmacopoeia. The GMP-compliant productions of PET tracers are conducted nearly on a daily basis. The preparation of an application for manufacturing authorization for a new PSMA ligand, namely [18F]PSMA-1007, is ongoing. [18F]PSMA-1007 was developed in our division and holds great promise as a specific PET tracer for the imaging of PSMA in prostate cancer.

 

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. [18F]FAZA, [18F]FDOPA, and others.

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