WuXi AppTec, Inc. Bioanalytical Services Unit Receives GLP Certificate from OECD and EU
Published: Aug 23, 2011
SHANGHAI, Aug. 23, 2011 /PRNewswire-Asia/ -- WuXi AppTec announced today that its Bioanalytical Services (BAS) unit had 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 (absorption, distribution, metabolism, and excretion) studies, toxicokinetic and pharmacokinetic studies, and hERG assay and biomarker studies with respect to OECD and EU principles of Good Laboratory Practice. Award of the certificate followed a thorough review of the facility operations and records on May 9-11, 2011, by Belgian authorities.
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. Food and Drug Administration (FDA) in March 2009 and an inspection by China's State Food and Drug Administration (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.
WuXi's Bioanalytical Services (BAS) was established in 2005. BAS provides GLP-compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy and to measure biomarker/biologics and antibody immunogenicity using immunochemistry. It is the only bioanalytical laboratory in China to have passed SFDA, OECD, and FDA GLP inspections.
"We are very pleased to have passed this OECD/EU inspection," commented Dr. Ge Li, Chairman and Chief Executive Officer of WuXi AppTec. "WuXi will continue to pursue the highest levels of quality and transparency to meet and exceed international requirements."
"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."
About WuXi PharmaTech and WuXi AppTec
WuXi PharmaTech (NYSE: WX) is a leading pharmaceutical, biotechnology, and medical device R&D outsourcing company, with operations in China and the United States. As a research-driven and customer-focused company, WuXi PharmaTech provides a broad and integrated portfolio of laboratory and manufacturing services throughout the drug and medical device R&D process. WuXi PharmaTech's services are designed to assist its global partners in shortening the cycle and lowering the cost of drug and medical device R&D. WuXi PharmaTech's operating subsidiaries are known as WuXi AppTec. For more information, please visit: http://www.wuxiapptec.com .
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WuXi PharmaTech (Cayman) Inc.
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Director of Investor Relations
Stephanie Liu (for the media)
WuXi PharmaTech (Cayman) Inc.
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