Metabolite Profiling and Balance Studies (14C-Labeled Drug)

With over 25 years of experience, SGS’s Life Science Services provides ADME clinical studies and complete analysis with radiolabeled compound.

SGS is your ideal partner in metabolite profiling and mass balance studies because of the following integrated capabilities:

• Analysis and clinical trials executed in collaboration with SGS’s own Phase I unit in Belgium
• Mass balance established in six to eight studies in human per year
• Human metabolism studies by advanced LC-MS/MS and other technologies (QTrap, QTof, TopCount)
• Liquid scintillation counting and sample combustion for radiocarbon determination (mass balance studies)
• Determination of protein binding
• HPLC with on-line radio detector and MS for metabolic profiling
• Analysis of unlabeled drug by LC-MS/MS

Production and GMP controls

SGS has the complete infrastructure in place to prepare and formulate radiolabelled compounds under full GMP control. The area has been designed as a clean room area, with access through SAS and passboxes, and the necessary pressure controls, to protect the product and the environment at the same time. All production is overseen, and released by an expert qualified person, while a trained radiopharmacist keeps check of the radiological aspects of the products and the processes.

Microdosing

SGS has performed microdosing studies at its clinical units, and collaborates for the analytical part with a selected partner that provides the highly sensitive analytics (accelerator mass spectrometry) required to quantitate the radioactivity in the biological samples derived from these clinical studies.