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 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.