Founded in 1997, Xceleron is the global leader in predictive clinical research to enable smarter, safer drug development decisions. With facilities in the U.S. and Europe, Xceleron is a proven partner to a range of over 100 pharma-biotech businesses, both private and public, adding value through optimization of Exploratory Clinical Development programs.
Xceleron is expert-acknowledged to deliver a range of smart approaches to Exploratory Clinical Studies in Microdosing, Mass Balance, IV-PK including Absolute Bioavailability, and Metabolite Profiling. The information we generate enables our partners to exercise informed decisions on new candidate drugs faster and more cost-effectively than with competing technologies.
Xceleron has its own substantive and innovative R & D unit which, in association with worldwide drug developers, continues to develop new methods for ultra-sensitive analytical services including Accelerator Mass Spectrometry (AMS) molecule analysis, drug-drug interactions, metabolic-markers, protein labeling, standards and clinical data interpretation.
At Xceleron, we believe that our services reduce time and resources needed to get drugs to market. By obtaining more useful data earlier in development, fewer mistakes are made later on.
We are the pioneers of the Human Microdosing / Phase Zero technique, which utilizes sub-therapeutic doses of non-GMP drug to rank order drug candidates, obtain initial proof of concept data and to verify tox species when conflicting animal data is obtained. Our ultra-sensitive enabling technology is also used to obtain critical ADME/PK, including IV-PK, information data in a Phase I using a therapeutic dose of drug.
With 10 years of experience in this field, our specialized knowledge makes us the leaders in obtaining ADME/PK information data in both Phase Zero and Phase I settings where conventionally this would be left until much later. We have worked with over 100 companies and our techniques have been used by our clients in their submissions to regulatory bodies in both the US and Europe.
Xceleron applies AMS technology to the following key areas of biomedical research:
In a Phase Zero setting
Xceleron has two locations: Xceleron Ltd in York, UK, and Xceleron Inc in Germantown, MD, USA. Both sites are fully equipped with full laboratory facilities.
Human Microdosing: Using a sub therapeutic dose of non-GMP drug right out of discovery.
In a Phase I setting
IV-PK Studies: Conducted with minimal additional tox to support the sub-therapeutic IV dose.
META-ID™ Studies: Metabolism data available as early as Phase I. The answer of the FDA ‘Safety Testing of Drug Metabolites’ Feb 2008.
Regulatory Mass Balance Studies: Using nano Curies levels of 14C. No need to carry out dosimetry to justify 14C dose.
Tracking the metabolic fate of biologics: and overcoming common analytical challenges.
Last Updated: 08-25-2008