Carbon-14 labelled API and IMP requirements for Phase 0/I to Phase III mass balance and micro-dosing clinical trials can be met by contract manufacturing in compliance with MHRA and FDA Phase I cGMP guidelines. The short supply and escalating price of carbon-14 labelled building blocks has emphasised the demand for robust synthetic methodologies to incorporate the carbon-14 label efficiently into the API, and outsourcing to a CMO specialising in handling these challenges is a cost-effective approach. Further advantages accrue to clients by incorporation of these services within an overall drug development package, from discovery through to marketing.
One consequence of an increasing demand from regulators for robust quantitative data on the behaviour of new drugs in man and for information on the fate of pharmaceuticals in the environment, has been an increase in demand for carbon-14 labelled compounds. This article focuses on the new uses for C-14 compounds, factors impacting on their preparation and how C-14 custom labelling suppliers are responding to meet new demands.