The 314,000 sq ft facility in Suzhou in eastern China was completed in 2008 and currently performs non-good laboratory practice (GLP) toxicology work, as well as client-sponsored GLP validation studies.
Validation studies are one component of WuXi’s efforts to achieve GLP compliance. The company has initiated in-house GLP training and has now turned to Johnson & Johnson (J&J) Pharmaceutical R&D for additional support.
J&J Pharmaceutical R&D, a division of Janssen Pharmaceutica, will provide WuXi with training and other services to help establish the GLP quality system and technical capabilities needed to meet international standards.
This supports the “substantial progress” WuXi has made in training its technicians to perform GLP studies. By taking these in-house and external measures WuXi believes it can achieve its goal of offering GLP toxicology studies by mid-2010.
WuXi will reimburse Janssen for its support and supply the pharma with toxicology and other non-clinical services. An existing agreement between the companies was already in place and the new collaboration builds on this.
Suzhou gains AAALAC accreditation
The deal with Janssen follows the approval of the Suzhou site by the Association for the Assessment and Accreditation of Laboratory Care International (AAALAC). This signifies that the site’s animal care and research practices meet accepted standards.
WuXi’s facility in Suzhou houses 108 animal rooms which are a key component of the company’s efforts to become a leading provider of non-clinical safety testing in China.
"This accreditation continues to demonstrate WuXi's ability to provide our global customers with high quality service in a regulatory compliant environment”, added Ge Li, chairman and CEO of WuXi.