Aug. 22, 2011
WuXi AppTec reported on September 2011 that it has been given a certificate of Good Laboratory Practice (GLP) for its Bioanalytical Services (BAS) unit from European regulatory authorities. With the new certificate WuXi is authorized to carry out European-approved ADME (absorption, distribution, metabolism, and excretion) studies, toxicokinetic and pharmacokinetic studies, and hERG assay and biomarker studies.
This represents WuXi's third successful audit of its bioanalytical lab by regulatory authorities. The facility also passed a bioequivalence study inspection by the U.S. FDA in March 2009 and an inspection by China's SFDA supporting the certification of WuXi's GLP toxicology operation in Suzhou. The BAS laboratory is now certified by the SFDA and OECD to provide GLP-compliant support for nonclinical studies. In addition, this laboratory is certified by the OECD to support clinical trials for small-molecule and biologics pharmacokinetics and biomarker analysis.