Bioanalytical

Bioanalytical services at WuXi AppTec offers comprehensive and FDA/OECD/SFDA GLP-compliant bioanalysis services to support drug discovery, preclinical and clinical development for pharmaceutics, biologics, biomarkers and antibodies.

GLP Bioanalytical Services

LC/MS/MS Bioanalysis
- Includes method development and validation, sample analysis, and synthesis of reference standard and labeled internal standards.
Immunochemistry
- Includes assay development and validation, sample analysis, multiplexassay, and immunogenicity assay.

Client & Regulatory Agency Inspection

Inspected by US FDA in March 2009 without 483
Numerous studies inspected by China SFDA without any findings
Passed GLP QA audit from 15 multinational pharma/biopharma companies

Service Features

Studies
- Preclinical/Clinical PK
- Toxicokinetic
- Preclinical/Clinical PD
- Immunogenicity
Instrumentation
- API 4000/5000
- MSD Sector Imager 6000
- Molecule Devices M2/M5 reader
- Tecan Evo Workstation
- Luminex 200
Turnaround Times & Throughput
- Method development (1- 4 weeks)
- Method validation (2 weeks)
- Sample analysis (8,000 samples/week)
Other Features
- Validated Watson 7.2 LIMS for sample and data management
- Study-dedicated instrument and scientist
- Dedicated QC team
- Strong logistical support for receiving material and biological samples sent from anywhere in the world
- To synthesize reference standard and stable-labeled internal standards