Bioanalytical method development, validation and establishment

WuXi/XBL is equipped with AB/Sciex and Waters Xevo TQ-S LC-MS instrumentation to provide both routine and innovative bioanalytical research and support services.

WuXi/XBL provides comprehensive bioanalysis study services

• Biological sample assays, including human and animal plasma, urine and feces, in vitro extracts
• LC/MS and LC/MS/MS bioanalytical method development and validation for new drugs and their metabolites or generic drug assay
• Non –clinical and clinical sample assay of parent drug and metabolites to support PK,TK,BA,BE, and DDI studies
• Fully GLP-compliant, non-GLP PK support or higher throughput Discovery level analysis
• HPLC UV analytical method development
• Full or partial method validation in multiple species and matrices according to FDA and EMA guidelines
• Cross-validation of established methods
• Multi-analyte and Chiral method development

Global locations and capacity(NJ and China)

• 80+ instruments for GLP bioanalysis
• 200+ validated assays

Wide-ranging Instrumentation and laboratory support

• Dedicated LC-MS systems and lab space
• AB/Sciex - API 6500, API 5000, API 4000, API 3000
• Waters Xevo TQ-S
• Thermo Q ExactivePlus
• Waters UPLC, Shimadzu UFLC XR
• Tomtec and PE Janus liquid handling systems
• Analyst, MassLynx, Empower, Watson LIMS, 21CFR11 validated systems