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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

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.

Shanghai, China
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

Suzhou, China
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.

100+

Active Clients

500+

Global Bioanalytical Staff

2,000+

Global Clinical Trials Supported

1M+

Bioanalytical Samples Analyzed Per Year