Celerion’s facility in Lincoln, Nebraska is licensed to conduct studies with radiolabeled compounds. The ADME (Absorption, Distribution, Metabolism and Excretion) Suite includes 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.
Celerion has the 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. Celerion has access to a skilled radiochemical synthesis group as well as to specialists in metabolite isolation and identification from biomatrices. Radiolabel dosage forms suitable for administration to humans can be readily prepared at Celerion’s purpose-built pharmacy clean room at the Lincoln facility. The Lincoln clinic can also conduct micro-radiotracer studies, making it one of the few organizations globally capable of conducting specialized human ADME studies to regulatory standards.
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 notebook system thereby increasing data compliance.