CLEVELAND, Jan. 14, 2013 /PRNewswire/ -- ChanTest announced today the capability to perform a bioassay in conformance with current Good Manufacturing Practices (cGMP)*. The in vitro assay involves higher throughput Ussing chamber experiments for measuring inhibition of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) chloride ion channel short circuit current, a measure of chloride ion secretion. ChanTest passed its first regulatory inspection related to this cGMP bioassay at the end of last month.
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In 2000, ChanTest began initiating assays related to hERG potassium channels in accordance with FDA Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies (21 CFR Part 58). The new cGMP testing capability allows ChanTest to offer a unique service to the pharmaceutical and biotech industry. ChanTest will offer cGMP bioassays for release of natural products (i.e., botanicals) and any drug working via ion channels, GPCRs or transporter targets for which analytical testing is not possible.
Arthur “Buzz” Brown, M.D., Ph.D., CEO at ChanTest said, “ChanTest is extremely excited to bring this unique cGMP testing service to the pharma community. This means that we can now partner with pharma and biotech companies to bring safe medicines to market from the beginning to the very end of the drug development process.”
ChanTest offers screening service with the Ussing assay for important transporters targets. Ussing experiments involve measuring electrical currents across epithelial cells under voltage clamp conditions.
*Conformance: |
United States Pharmacopeia (USP) |
USP Chapter 1032; Design and development of biological assays |
USP Chapter 1033; Biological assay validation |
cGMP Compliance: |
21 CFR Part 210 and 21CFR Part 211 |
About ChanTest The Ion Channel Expert
ChanTest’s mission is to serve the drug discovery and development needs of customers worldwide with high-value solutions for ion channel and GPCR biology. Since its inception in 1998, the CRO has tested compounds for more than 500 global pharmaceutical and biotechnology companies and partners with them to speed the drug development process for the release of better, safer drugs. ChanTest offers integrated ion channel and GPCR services (GLP and non-GLP) and reagents; the company’s library of validated ion channel cell lines and nonclinical cardiac risk assessment service portfolio is the most comprehensive commercially available today. Because of ChanTest’s seminal role in the nonclinical cardiac safety field, along with the company’s uncompromising commitment to quality, ChanTest has been named the “most trusted and most used fee-for-service provider” for ion channel screening in an independent survey for the past several years. ChanTest is based in Cleveland, Ohio. For more information, e-mail info@chantest.com.
Chris Mathes, Ph.D.
Chief Commercial Officer
ChanTest Corporation
732-586-1073
cmathes@chantest.com
SOURCE ChanTest
