Xceleron is a specialized analytical CRO using robust analytical methodology and AMS detection technology to develop pharmaceutical products more quickly and less expensively than conventional analytical techniques. We work with integrity and an open mind and are driven by science and the spirit of collaboration.
Xceleron was founded in 1997 in York, UK, is now headquartered in Germantown, Maryland and has customers located in America, Europe and Japan. Our customers use us 90% of the time to support human clinical investigations and 95% of those at therapeutic dose levels by the intended therapeutic route of administration. Most of our work involves small molecules but we are increasingly analyzing biologics such as antibody-drug conjugates.
Robust analytical methodology and AMS detection is now considered to be a valuable addition to the contemporary analytical “tool-box”. Many small molecule drugs today exhibit low solubility and long half-lives and benefit from early insight to their disposition afforded by AMS. Xceleron has demonstrated that use of AMS can result in small molecule development savings of six to 12 months compared to more traditional analytical techniques. Biologics such as antibody-drug conjugates exhibit complex multi-component disposition that benefit from the specificity and sensitivity of AMS.
Quality at Xceleron is measured by the production of representative, accurate, and precise data delivered on time to our clients. Our quality is assured by having rigorous Quality Control, Quality Assurance, and instrument capacity in Xceleron’s laboratory.
The quality of our data is our number one priority. Our robust sample preparation techniques are the result of 17 years of scientific insights. Xceleron scientists have developed a reliable approach to client analytical method transfer and validation. Our team is constantly working on ways to produce high quality data more efficiently.
Our laboratories are GLP and GCP compliant. The company has approximately 150 Standard Operating Procedures covering Study Conduct, Equipment, Operations, Organization, Health and Safety, and Quality Assurance.
Amgen used LC+AMS during determination of Pharmacokinetics, Biotransformation, and Excretion of [14C]Etelcalcetide (AMG 416) Following a Single Microtracer Intravenous Dose in Patients with Chronic Kidney Disease on Hemodialysis
"...AMS [is] an invaluable tool in our early drug development program, allowing us to quickly assess bioavailability in humans and focus resources on our most promising drug candidates going forward."
Find out how we can help you accelerate your drug-development program.