cGMP Radiosynthesis for Early Phase Clinical Trials: A Unique Challenge and Development of a Standard Process

Radiolabeled drugs are used in human ADME and bioavailability studies. The synthesis of radiolabeled compounds sometimes requires development of new synthetic pathways which can be significantly different from the traditional synthetic pathway. The radiolabeled drug can have different stability and impurity profiles from the non-labeled drug and thus require special considerations. These special considerations may pose challenges in ensuring cGMP compliance and safety for the patient during the clinical trial. This whitepaper discusses the challenges associated with radiolabeled synthesis coupled with maintaining CGMP compliance for the synthesis and analytical portions of the program.

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