WuXi AppTec's Bioanalytical Services (BAS) unit has received a certificate of Good Laboratory Practice (GLP) from the Organization for Economic Cooperation and Development (OECD) and the European Union (EU). The certificate states that WuXi's BAS facility in Shanghai is able to carry out ADME, toxicokinetic and pharmacokinetic studies, and hERG assay and biomarker studies with respect to OECD and EU GLP principles. The facility underwent review on May 9-11, 2011 by Belgian authorities.
This represents WuXi's third successful audit of its bioanalytical lab by regulatory authorities, according to a company statement. The facility also passed a bioequivalence study inspection by the 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, the laboratory is certified by the OECD to support clinical trials for small molecule and biologics pharmacokinetics and biomarker analysis.
WuXi's BAS unit was established in 2005 to provide services to analyze small molecule drugs using liquid chromatography/mass spectroscopy and to measure biomarker/biologics and antibody immunogenicity using immunochemistry.
"As a GLP-compliant facility, BAS always treats quality and compliance as our highest priorities," commented Dr. Jinsong Xing, Vice President of BAS of WuXi AppTec. "We maintain GLP readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data and closely monitors the facility for compliance on a daily basis."