JCL Bioassay USA, Inc. and Xceleron Announce Partnership in Early Clinical Investigations
Published: Mar 19, 2013
The partnership will offer drug developers access to the broadest range of sensitive and robust analytical platforms in early clinical development across Asia, Europe and North 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 development allow critical decisions to be made confidently and very cost-effectively when compared to later stages of clinical development.
The partnership between JCL Bioassay USA and Xceleron will provide access to clinical design expertise and the most appropriate Bioassay platform for the purpose of early clinical investigation. JCL Bioassay USA and Xceleron have between them developed over 100 analytical methods for Phase 0 and enriched Phase 1 investigations. This has been made possible because both companies have recently constructed, equipped and staffed laboratories specifically for the purpose of ultra-low level analyses under GLP and GCP conditions.
“With 27 years experience in providing services for Bioassay work coupled with the most state -of-the-art analytical instruments, our researchers are well positioned in conducting ultrasensitive bioanalysis. 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 cost-effective 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.
“This partnership emphasizes the critical role of contemporary analytical platforms in driving down the cost per launch. Whether in Phase 0 or enriched Phase I, we can confidently provide critical PK and PD information cheaply before Phase II” said Dr. Michael Butler, CEO of Xceleron.
About JCL Bioassay USA, Inc.
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 in 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. For more detailed information, visit JCL Bioassay USA at www.jclbiousa.com.