ABC White Paper: "CGMP Radiosynthesis for Early Phase Clinical Trials: A Unique Challenge and Development of a Standard Process"

By Wayland Rushing, Ph.D., Kevin Roberson
Analytical Bio-Chemistry Laboratories

Radiolabeled products are used extensively during pre-clinical studies in BA/DMPK studies. The material used for these studies is typically research grade material released under Good Laboratory Practices (GLP’s). However radiolabeled drugs are also used during ADME and bio-availability studies. Since the products are now intended for use in human studies, they now must comply with CGMP regulations in terms of its manufacture and release testing. 

Radiolabeled drugs are used in Human ADME and bio-availability studies. While the regulatory requirements for traditional “cold” clinical trial materials are well understood, the regulatory requirements for radiolabeled are much less understood by industry. 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 significantly different stability and impurity profiles from the non-labeled drug and thus require special considerations. These special considerations may pose challenges in terms of ensuring CGMP compliance and safety for the patient during the clinical trial.

This White Paper discusses the challenges associated with radiolabeled synthesis coupled with maintaining CGMP compliance for the synthesis and analytical portions of the program.

Click here to download this ABC White Paper