Celerion expands ADME suite in Lincoln, Nebraska
Now able to carry out on-site scintillation counting
Celerion has expanded its ADME (Absorption, Distribution, Metabolism and Excretion) suite in Lincoln, Nebraska.
This US provider of early stage drug development solutions has invested in equipment and laboratory space to perform on-site scintillation counting, allowing radioactivity recovery results to be delivered in real-time. This service ensures high total recovery of radioactive dose while providing for efficient clinical study conduct.
The newly expanded ADME suite adds to Celerion’s capabilities to manage all aspects of human radiolabelled ADME studies from synthesis and formulation of an appropriate radiolabelled drug through dosimetry assessment and clinical conduct to final isolation, identification and quantification of metabolites in the samples collected.
Radiolabel dosage forms suitable for administration to humans can be prepared at Celerion’s purpose-built pharmacy cleanroom at the Lincoln facility. This clinic also conducts micro-radiotracer studies, which makes the firm one of a few organisations globally capable of conducting specialised human ADME studies to regulatory standards.
‘The enhancement in our facility was driven by client needs, including a growing interest in conducting these critical studies earlier in a drug’s development,’ said Raymond Farmen, Celerion’s vp of Global Bioanalytical Services. ‘This is a response to regulatory guidances concerning knowledge of human metabolism and metabolites during safety assessment.’
