Achieving good laboratory practice (GLP) compliance is a key step in the development of the Suzhou site. Furthermore, GLP compliance is an important element of WuXi PharmaTech’s wider goal of providing a fully integrated platform of biopharm research and development services.
In September the Suzhou site was certified GLP by the Organization for Economic Cooperation and Development (OECD). Accreditation from the Chinese State Food and Drug Administration (SFDA) has followed, making it the first Chinese site to receive certification from both bodies.
"This certificate from the SFDA is an important milestone in offering our clients toxicology studies that meet both domestic and international GLP quality standards for filing INDs both in China and other countries", said Ge Li, chairman and CEO of WuXi.
Since opening the 314,000 sq ft site in 2008 WuXi has performed non-GLP toxicology studies while working towards achieving GLP compliance. WuXi has received support from Johnson & Johnson and performed client-sponsored GLP studies as part of efforts to achieve compliance.
Having been certified WuXi will support investigational new drug (IND) applications In China and other countries by performing GeneTox, toxicokinetic studies and single-dose and multiple-dose toxicology in both rodents and non-rodents.
WuXi AppTec has entered into an agreement with Chemical Abstracts Service (CAS) to provide SciFinder to all its scientists. SciFinder gives users access to CAS content, such as chemical synthesis information, to boost the effectiveness of research and development efforts.
“As a knowledge-based, problem-solving provider of broad chemistry-based services, WuXi will have instant access to more than 10,000 journals and 61 patent authorities, using an intuitive interface to seek out the latest in state-of-the-art research”, said Li.