Xceleron has announced a partnership with China-based Crystal Pharmatech that will offer drug developers early bioavailability data and optimized solid-state forms and formulations. Together they can cost-effectively remove pharmacokinetic uncertainty and enable their customers to make better decisions sooner about a candidate’s later-stage readiness.
(Germantown, MD, USA; January 22, 2013) — Xceleron, a U.S.-based leader in the application of ultra-sensitive analytical technology to novel clinical designs, has announced a partnership that will offer drug developers early bioavailability data that will lead to optimized solid-state forms and formulations. The partnership with Crystal Pharmatech, a China-based, technology-driven, solid-state research CRO, will enable sponsors to make faster decisions in the early stages of development.
Contemporary small molecules represent a challenge in translational development due to their physicochemical properties and the low predictivity of traditional nonclinical biological models. Too frequently, drug efficacy suffers because of poor pharmacokinetic properties.
The partnership between Xceleron and Crystal Pharmatech provides a solution. They combine the accelerator mass spectrometry (AMS) technology with the expertise to cost-effectively remove pharmacokinetic uncertainty by providing better early clinical and solid state information. This enables their customers to make better decisions sooner about a candidate’s later-stage readiness.
“At Xceleron, we believe that technology can get life-changing drugs to people who need them, sooner and at a lower cost. This partnership will help our clients do that by efficiently and cost-effectively answering critical questions earlier,” said Dr. Michael Butler, CEO of Xceleron.
“Having robust bioavailability and pharmacokinetic data at the outset provides a strong foundation for determining the best solid form and formulation,” added Dr. Alex Chen, CEO of Crystal Pharmatech. “Each company brings significant expertise to the discussion of novel clinical outcomes.”
Xceleron provides bioanalytical AMS services for accelerated early drug development. The company pioneered human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I and Phase II/III clinical trials. It has been providing drug development services for more than 10 years and has conducted more GLP and GCP studies than any other analytical service provider of its type.
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.