The Bioanalytical Services Unit provides the only GCP laboratory certified by the FDA, OECD, EMA and CFDA in China at present. The laboratory primarily supports clinical sample analysis but also supports the nonclinical activities of WuXi AppTec’s various business units such as the non-GLP laboratory in Shanghai that supports DMPK activities and the GLP laboratory in Suzhou (a suburb of Shanghai) that supports toxicology studies. Additionally in October 2014, WuXi AppTec acquired XenoBiotic Laboratories, Inc. in Plainsboro, NJ, USA. The XBL laboratory is able to supplement WuXi AppTec’s bioanalytical capabilities in a more convenient location for our Western clients. Our management staff have all been trained overseas with extensive experience in both the CRO and Pharma industries. The training they offer is very high quality, even being selected to lead joint training programs with the CFDA. The staff are experts in the quantitative analysis of both small and large molecule data for nonclinical through phase IV clinical trials and provide these services to customers worldwide. As of 2013, we have conducted more than 100 clinical studies for submission to the CFDA and supported more than 2,000 global and domestic clinical trials making us the preferred vendor for 6/20 of the top international and 3/10 of the top domestic Pharma companies.
Small and large molecule sample analysis supporting preclinical through Phase IV studies. (Learn More)
Clinical immunology, pathology and genetic biomarker analysis in support of PK/TK/PD studies. (Learn More)