XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec
Thursday, June 22, 2017

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