Navigation Links
WuXi AppTec Bioanalytical Services Unit Receives GLP Certificate from OECD and EU
Date:8/23/2011

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 .

For more information, please contact:

WuXi PharmaTech (Cayman) Inc.

Ronald Aldridge (for investors)
Director of Investor Relations
Tel:   +1-201-585-2048
Email: ir@wuxiapptec.com

Stephanie Liu (for the media)
WuXi PharmaTech (Cayman) Inc.
Tel:   +86-21-5046-4362
Email: pr@wuxiapptec.com


'/>"/>
SOURCE WuXi PharmaTech (Cayman) Inc
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. WuXi AppTec and QIAGEN Enter into Partnership Agreement for Molecular Biomarker Development
2. Cetero Research Names Dr. Roger Hayes President of Bioanalytical Operations
3. QPS Expands Phase 1 and Bioanalytical Capability by Acquisition of Bioserve, India
4. MicroConstants Completes Installation of Latest LC/MS/MS Technology to Achieve Improved Sensitivity in Bioanalytical Method Development
5. PharmaNet Experts to Showcase Bioanalytical Posters at ASMS 2011
6. PharmaNets Bioanalytical Laboratory Recognized by the Standards Council of Canada for Good Laboratory Practice Compliance
7. PharmaNet Names Dr. George Scott Vice President of Bioanalytical Services
8. West Pharmaceutical Services, Inc. Appoints New Director
9. PAREXEL Expands Late Phase Clinical Research Services and Appoints Leading Pharmacoepidemiology Expert Victor Kiri
10. U.S. Department of Health and Human Services Completes Funding of 2006 Contract Award to CSCs DVC and Baxter
11. Caliper Life Sciences Introduces Drug Combination Services to Identify Synergistic Response of Compounds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/14/2017)...  In 2016, Embodied Labs took top ... and came away with $25,000 in seed-fund investment. Embodied ... as "entering the life of another" and by the ... to medical professionals in an entirely new dimension." Building ... finalist for the Department of Education,s EdSimChallenge, where they ...
(Date:6/11/2017)... , June 10, 2017  Eli Lilly and Company ... from three Phase 3 studies of galcanezumab, an investigational ... including late-breaking data on several key secondary endpoints for ... results from these studies (EVOLVE-1, EVOLVE-2 and REGAIN) will ... annual scientific meeting in Boston . ...
(Date:6/9/2017)... and INDIANAPOLIS , June ... are living with diabetes. In a further effort to ... people affected by this condition, the International Diabetes Federation ... LLY ) have come together for the second phase ... and Systems programme (BRIDGES 2), reaffirming their commitment to ...
Breaking Medicine Technology:
(Date:6/26/2017)... (PRWEB) , ... June 26, 2017 , ... Torrance dentist, ... aesthetics can be one of the most noticeable aspects of a person’s appearance. A ... not everyone is born with beautiful, balanced teeth, everyone can have the smile of ...
(Date:6/26/2017)... ... June 26, 2017 , ... Dr. Martin ... Specialists, in collaboration with the Fertility Center of California, is pleased to announce ... epidydimal sperm aspiration) and TESA (percutaneous testicular sperm extraction). These minimally invasive treatments ...
(Date:6/26/2017)... ... June 26, 2017 , ... ... recent review of government data released by the United Soybean Board. , ... Maryland’s soybean farmers have increased their productivity on less land per bushel, the ...
(Date:6/26/2017)... ... June 26, 2017 , ... LARKR™ , an innovative ... in every state across the country to join its online treatment platform. , ... therapists to reach a substantially greater number of people in need nationwide, and to ...
(Date:6/26/2017)... ... 26, 2017 , ... KICKICO , a protocol built on Ethereum for ... many catastrophic issues within funding campaigns. KICKICO developers are testing the platform, which will ... the raising of funds through the power of many - has been around for ...
Breaking Medicine News(10 mins):