Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced that it has made a significant investment in its ADME (Absorption, Distribution, Metabolism and Excretion) suite of services to meet continuously increasing demand to conduct these studies. This investment includes expanding laboratory space, adding new capabilities as well as a dedicated customer service team.
The leader in early clinical development
expands ADME suite to meet
ongoing demand.
Celerion, a
clinical research organization (CRO) to the biopharmaceutical industry, has
announced that it has made a significant investment in its ADME (Absorption, Distribution, Metabolism
and Excretion) suite of services to meet continuously increasing demand to
conduct these studies. This investment includes expanding laboratory space,
adding new capabilities as well as a dedicated customer service team.
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. What’s more, this investment
has also enabled Celerion to double capacity of lab throughput.
In addition to running human ADME
studies, Celerion offers innovative metabolite identification and profiling. Celerion is one of the few laboratories using the newest and
most advanced High Resolution Mass Spectrometry (HR-MS) Metabolite Profiling
and Identification instrumentation and technologies to identify major
metabolites, important metabolites (MIST), and unique metabolites.
“With over 100 radiolabeled studies
and 800 participants dosed, our experience in ADME studies ensures clients’
studies run efficiently and effectively from initial planning through to the
final report,” said Phil Bach, Celerion’s Vice President of
Global Clinical Research. “Additionally, our clinical and bioanalytical
services are located within the same facility, enabling faster access to
quality data and savings in time and cost.”
Celerion has dedicated pharmacy
staff consisting of Pharm D’s and registered technicians with over 40 years of
Phase I experience. We have an authorized nuclear pharmacist to run all ADME
studies and assign a lead pharmacist to each new study. The pharmacist will be
involved with the study from start-up to close out and available for any
consultation needed. All pharmacy staff are cross-trained on all protocols and
all pharmacy functions. “From compounding formulation through data received our
dedicated operational team along with a nuclear pharmacist and lab director
work to provide a one stop shop for all of your ADME needs”, Bach added.
About Celerion
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 over fifty years, Celerion has
leveraged the latest operational concepts and technologies to execute
safety/tolerability, pharmacokinetic, and pharmacodynamic 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. In addition, Celerion offers
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 family, friends and people in need
around the world. For more information, please visit www.celerion.com.