The development of new drugs is a challenging compromise between time/cost projections and safety/efficacy profiles. Every day lost in the development of a successful drug leads to a direct loss in revenue for the pharmaceutical or biotechnology company.
Carbon-14 labeled 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 labeled building blocks has emphasized the demand for robust synthetic methodologies to incorporate the carbon-14 label efficiently into the API, and outsourcing to a CMO specializing in handling these challenges is a cost-effective approach.
This article published in the Winter 2012/13 edition of Drug Discovery World looks at these challenges and identifies further advantages of outsourcing these services to a CMO, from drug discovery stage to marketing.