GMP synthesis of radiolabeled compounds expertise solves safety and efficacy challenges

Craig Schouten, Vice President of Operations, Eurofins BioPharma Product Testing Columbia

Few laboratories have the expertise and systems to perform a GMP synthesis of radiolabeled compounds for human mass balance studies. Eurofins BioPharma Product Testing’s radiolabeling and custom synthesis services offer state-of-the-art facilities and an experienced team to support client’s synthetic needs.

Our team is equipped to handle a range of projects from custom small-scale synthesis of compounds and reference standards to the manufacture of 14C labeled API for early phase clinical trials in compliance with FDA phase 1 GMP guidance (IQCH Q7a Section 19).

Whether you need radiolabeled compounds for preclinical studies or clinical metabolism studies, our experts can provide guidance on synthetic procedures to meet your specific needs. Our dedicated analytical team can provide assurances on the safety and efficacy of the radiolabeled compounds both on release and stability.

At Eurofins, we have the expertise, facilities, and systems to provide effective, timely, and quality production of radiolabeled compounds.