Global Bioanalytical Solutions
WuXi AppTec’s Laboratory Testing Division offers comprehensive quantification and analysis for small and large molecule drugs and/or metabolites and biomarkers from discovery through preclinical and clinical development. Leveraging institutional expertise, world-class facilities and the latest instruments and technologies, our Bioanalytical Services Unit is committed to delivering quality results for our clients and therapeutic value for patients worldwide.
Service & Quality
The Bioanalytical Services Unit provides liquid chromatographic-mass spectrometric (LC-MS/MS) and ligand binding analysis (LBA) to enable IND, NDA, BLA and ANDA packages. Our diverse discovery, preclinical and clinical bioanalytical strategies are fully integrated with other services at the Laboratory Testing Division, which enables us to carry your compound from discovery through clinical phases for increased efficiency and an accelerated timeline.
- Discovery rapid turnaround bioanalysis
- Preclinical bioanalysis using qualified and validated methods
- Clinical bioanalysis using qualified and validated assays
Dedicated Global Facilities
Operating out of four state-of-the-art facilities throughout Asia and North America, the Bioanalytical Services Unit houses the largest bioanalytical laboratory in Asia. Our regional flexibility and worldwide expertise allow us to fully support our global drug discovery and development customers with end-to-end bioanalytical solutions to meet their varying needs.
Operations & Compliance
Under the authority of quality assurance teams skilled in global regulatory guidelines and GLP requirements, the Bioanalytical Services Unit is fully committed to the integrity of its scientific data, equipment and infrastructure in accordance with WuXi’s established quality processes.
The first GLP laboratory in China to pass inspections by the US FDA, CFDA and EMA, our bioanalytical lab in Shanghai maintains a clean regulatory track record, and has passed numerous GLP Quality assurance audits.
- GLP inspection and certification by OECD health authorities
- US FDA BE and EMA compliance
- China FDA provincial compliance
- Data accepted by worldwide health authorities
Located within our state-of-the-art toxicology facility, the Suzhou bioanalytical lab supports toxicology services for our global clients. The Tox Bioanalytical Services Unit has consistently passed inspections by the FDA, CFDA and OECD.
- GLP Inspection and audited by CFDA, FDA and OECD health authorities
- On-site support for all in vivo GLP Tox studies and PK studies
- Integrated study flow from PK to Tox and Safety pharmacology
Plainsboro, New Jersey
For nearly 30 years, the New Jersey bioanalytical facility has maintained a strong record of successful regulatory submissions and agency auditing records, which is supported by our standardized training, documentation and reporting systems.
- Strong regulatory audit history
- Regularly inspected by US FDA
- Yearly / biannual repeat site qualification for major innovator and generic pharma
- 100% of data accepted by clients and regulatory authorities
Track Record of Success
Within the Bioanalytical Services Unit, we have the human capital, financial strength and global capacity to handle your project in its entirety, having supported thousands of global clinical trials to date and maintaining preferred vendor status with 6 of the top 20 global pharmaceutical companies.