Celerion announced today the expansion of specialized high-resolution mass spectrometry (HR-MS) profiling capabilities demonstrating their commitment to further assisting sponsors in meeting the regulatory requirements to characterize and quantify drug metabolites and their potential for impacting drug effect as part of the process to becoming an approved therapeutic product.
Celerion has created a compelling bioanalytical offering to support drug development at all stages, from in vitro metabolite identification to human ADME profiling studies via SCIEX TripleTOF® 6600+ instrumentation coupled with v.ARC 3 online radiodetection and the latest software packages.
"Celerion is pleased to provide this much-needed service to our bioanalytical clients. This metabolite identification capability rounds out our well-known ADME Human Mass Balance offering. We can now continue to work with our clients to define the radiometabolite profile of their drug following human administration to complement earlier in vitro data and further guide drug development," stated Petra Struwe, Ph.D., executive director of the Zurich bioanalytical laboratory.
"These advances enable our clients to rapidly identify and quantify metabolites from human mass balance studies to better understand the potential metabolic breakdown products of novel investigational compounds which may contribute to suboptimal pharmacokinetics and potentially toxic metabolites or even drug-drug interactions," stated Ray Farmen, Ph.D., vice president of global bioanalytical sciences at Celerion. "This expansion is well-aligned with our 10-year anniversary, A Decade of Translating Science Into Medicine, exemplifying the scientific focus driving our success."
Discussing this in greater technical detail, Celerion's Matthias Sury, Ph.D., and Sergio Menta, Ph.D., will share "Metabolite Identification via High Resolution Mass Spectrometry: Overcoming Challenges of Met ID during Pre-clinical and Early Clinical Development" on June 11 during an upcoming Celerion ScienceSM Webinar.
About Celerion Inc.
Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path. For 50 years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamics studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. Celerion offers feasibility, data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly so that they touch the lives of our families, friends, and people in need around the world. For more information, please visit celerion.com.
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