New offering will expand access to powerful analytical platforms
Germantown, MD, USA, March 19, 2013 / B3C newswire / - Xceleron, a leader in the design and use of ultra-sensitive Accelerator Mass Spectrometry (AMS) in novel clinical investigations, has announced a partnership with JCL Bioassay, a leader in the use of highly sensitive LC-MS/MS and proprietary methodologies. The new partnership will offer drug developers access to the broadest range of sensitive and robust analytical platforms in early clinical development across Asia, Europe and N. America.
Phase 0 and enriched Phase 1 studies have been used successfully in recent years to investigate a range of developmental endpoints including drug presence at the tissue or cells of interest, absolute bioavailability and human metabolism. Investigations of this type conducted early in drug development allow confident critical decision-making that offers a very cost-effective alternative when compared to later stages of clinical development.
The partnership between Xceleron and JCL Bioassay will provide access to clinical design expertise and the most appropriate analytical platform for the purpose of early clinical investigation. Xceleron and JCL Bioassay have between them developed over 100 analytical methods for Phase 0 and enriched Phase 1 investigations and both companies have recently built, equipped and staffed laboratories specifically for the purpose of ultra-low level analyses under GLP and GCP conditions.
“This partnership emphasizes the critical role of contemporary analytical platforms in driving down the cost of drug development. Whether in Phase 0 or enriched Phase I, we can confidently provide critical PK and PD information before Phase II” said Dr Michael Butler, CEO of Xceleron.
“With 27 years’ experience in providing services for bioassay work coupled with-state-of-the-art analytical instruments, our researchers are well positioned to conduct ultrasensitive bioanalyses. This has led to the continuous growth of our company as a leader in the bioanalytical field and enables our customers to make rapid and precise decisions on their drug development programs. The partnership with Xceleron further expands the geographic and technological scope of the services we can provide to our customers and promotes the use of these cutting-edge analytical platforms to detect low level analytes in early drug development” said Jenny Lin, Vice President of Operations and CSO of JCL Bioassay USA, Inc.
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.
About JCL Bioassay
JCL Bioassay USA, located in Hoffman Estates, IL, is a leading Japanese CRO and a global provider specialized in Bioassay services in support of TK/PK studies for pre-clinical and clinical developments. The company provides cutting-edge capabilities and sophisticated expertise in Bioanalytical method development, method validation/qualification and study sample analysis for small and large molecules. The company also pioneered microdosing analysis in Japan. As a strategic drug development partner, JCL Bioassay USA helps sponsors to overcome challenges in Bioanalysis with expertise, rapid turn-around-time and high quality services.
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