In response to a growing interest in conducting human 14C-radiolabeled ADME studies earlier in drug development, Celerion has expanded its ADME suite in Lincoln, Nebraska. As discussed in the section on “ADME Studies in Early Clinical Development: Addressing MIST”, client demand for conducting human 14C ADME studies has continued to increase since the issuance of the MIST (Metabolites in Safety Testing) guidances from the FDA and ICH. These guidances encourage drug developers to identify and quantify human metabolites earlier in drug development and ensure that human metabolites have been adequately evaluated in non-clinical safety studies.
Celerion’s expanded ADME suite has a new HVAC system, chemical fume hoods, and LED lighting enabling analysis of light sensitive drugs. New oxidizers and scintillation counters were also installed. This equipment is interfaced with Celerion’s electronic laboratory notebook (ELN) system resulting in a virtually paperless bioanlaytical laboratory for all studies. Having the bioanalysis laboratory at the same site where the clinical 14C ADME study is conducted allows real-time scintillation counting to be performed. Clinical study conduct efficiencies are realized by real-time scintillation counting as study participants may be released from confinement earlier once total radioactivity recovery has been demonstrated. Furthermore, the Celerion site in Lincoln has developed efficient processes for obtaining the required regulatory approval from the State of Nebraska to perform radiolabeled human ADME studies. Access to the latest equipment in a state-of-the-art radiotracer laboratory combined with fully electronic data management and efficient sample handling processes demonstrate Celerion’s continuing investment to provide better data, faster for our clients.