Celerion announced that it has expanded its ADME (Absorption, Distribution, Metabolism and Excretion) Suite in Lincoln, Nebraska USA. Celerion has invested in new state-of-the-art equipment and laboratory space to perform on-site scintillation counting allowing for 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 radiolabeled ADME studies from synthesis and formulation of an appropriate radiolabeled 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 readily prepared at Celerion's purpose-built pharmacy clean room at the Lincoln facility. Considering that the Lincoln clinic can also conduct micro-radiotracer studies, Celerion is one of a few organizations globally capable of conducting specialized 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. This is a response to regulatory guidances concerning knowledge of human metabolism and metabolites during safety assessment," said Raymond Farmen, Vice President, Global Bioanalytical Services. "The on-site bioanalytical and Phase I clinical facilities in Lincoln offer seamless integration of services and data. For bioanalytical analyses, the ADME suite interfaces with Celerion's global electronic laboratory notebook system thereby increasing data compliance."