Caliper Launches GENSEP ™ FDA-compliant GLP Safety Pharmacology Service
- Expanded Services Include 70 Assays to Assess the Potential for Safety Liabilities of Investigational Therapies -
HOPKINTON, Mass., Sept. 27 /PRNewswire/ -- Caliper Life Sciences, Inc. (Nasdaq: CALP), a leading provider of tools and services for drug discovery and life sciences research, today announced the availability of its General Side Effects Profile (GENSEP™), a service offering through its Caliper Discovery Alliances and Services (CDAS) unit, to assess the potential for safety liabilities of drugs under Good Laboratory Practices (GLP). This milestone is another step in Caliper's strategy to offer a comprehensive and integrated solution that supports customers from drug discovery through investigational new drug (IND) submission. The ability to offer such services under GLP enhances the acceptance of these data when included in the drug candidates' regulatory filings.
"CDAS has always had a strong commitment to quality data, performing our safety pharmacology profiling under 'GLP-like' conditions, which are more than sufficient for most drug discovery and early development testing. However, the adoption of laboratory practices under full GLP compliance provides CDAS's customers with the option to perform an even greater level of quality assurance with our preclinical safety and predictive toxicity studies," said David Manyak, Ph.D., Executive Vice President, Drug Discovery Services of Caliper Life Sciences. "The ability to operate under GLP also facilitates CDAS's growing expansion in biomarker studies, allowing us to analyze clinical trial samples in addition to our preclinical biomarker detection activities, and moving Caliper further towards personalized medicine."
"The safety of experimental therapies, as well as marketed drugs, is coming under increased scrutiny from regulatory agencies worldwide, which is creating more demand for in vitro screening solutions that are predictive of safety or toxicity risk," said Kevin Hrusovsky, President and Chief Executive Officer of Caliper Life Sciences. "Caliper has a strategic focus on developing solutions that span the in vitro-to-in vivo bridge and bring our technologies into the clinical setting. A key foundational capability in this effort is the development of CRO services that are GLP-certified and that allow us to utilize Caliper's technologies to analyze clinical trials samples. We are at the forefront of developing and providing these solutions as evidenced by our pioneering role in safety pharmacology profiling, and through our involvement in validating predictive toxicity assays under the EPA's ToxCast program."
About Caliper Life Sciences
Caliper Life Sciences is a premier provider of cutting-edge technologies enabling researchers in the life sciences industry to create life-saving and enhancing medicines and diagnostic tests more quickly and efficiently. Caliper is aggressively innovating new technology to bridge the gap between in vitro assays and in vivo results, enabling the translation of those results into cures for human disease. Caliper's portfolio of offerings includes state-of-the-art microfluidics, lab automation and liquid handling, optical imaging technologies, and discovery and development outsourcing solutions. For more information please visit www.caliperLS.com.
Caliper is a registered trademark, and CDAS and GENSEP are trademarks, of Caliper Life Sciences, Inc. ToxCast is a trademark of the Environmental Protection Agency.
SOURCE Caliper Life Sciences, Inc.
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