Xceleron and JCL Bioassay announce partnership in early clinical investigations

Xceleron, a company heavily involved in the designand use of ultra-sensitive accelerator mass spectrometry (AMS) in novelclinical investigations, has announced a partnership with JCL Bioassay, whichhas a focus on the use of highly sensitive LC-MS/MS and proprietarymethodologies. The new partnership will, according to the pair, "offer drugdevelopers access to the broadest range of sensitive and robust analyticalplatforms in early clinical development across Asia, Europe and North America."

So-called "Phase 0" and "enriched Phase I" studieshave been used successfully in recent years to investigate a range ofdevelopmental endpoints, including drug presence at the tissue or cells ofinterest, absolute bioavailability and human metabolism, the companies say,adding, "Investigations of this type conducted early in drug development allowconfident critical decision-making that offers a very cost-effectivealternative when compared to later stages of clinical development."

The partnership between Xceleron and JCL Bioassay isexpected to provide access to clinical design expertise and the mostappropriate analytical platform for the purpose of early clinicalinvestigation. Adding to the value ofthe partnership, Xceleron and JCL Bioassay have, between them, developed morethan 100 analytical methods for Phase 0 and enriched Phase 1 investigations,and both companies have recently built, equipped and staffed laboratoriesspecifically for the purpose of ultra-low level analyses under GLP and GCPconditions.

"This partnership emphasizes the critical role ofcontemporary analytical platforms in driving down the cost of drug development,"said Dr. Michael Butler, CEO of Xceleron. "Whether in Phase 0 or enriched PhaseI, we can confidently provide critical PK and PD information before Phase II."

"With 27 years' experience in providing servicesfor bioassay work coupled with-state-of-the-art analytical instruments, ourresearchers are well-positioned to conduct ultrasensitive bioanalyses. This has led to the continuous growth of ourcompany as a leader in the bioanalytical field and enables our customers tomakerapid and precise decisions on their drug development programs," said JennyLin, vice president of operations and chief scientific officer of JCL BioassayUSA, Inc. "The partnership with Xceleron further expands the geographic andtechnological scope of the services we can provide to our customers andpromotes the use of these cutting-edge analytical platforms to detect low-levelanalytes in early drug development."