XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec XBL * A subsidiary of Lab Testing Division, WuXi AppTec Inc. WuXi AppTec
Wednesday, November 22, 2017

Sample analysis for PK and metabolite evaluation

WuXi/XBL's core capabilities are Bioanalysis of drug and metabolites including identifying and fully characterizing low-levels of drug and metabolites using state-of-the-art instrumentation and some of the most experienced staff in the industry.

WuXi/XBL provides comprehensive bioanalysis and metabolism study services

BioAnalytical Services

  • BA/BE/DDI clinical PK study sample analysis by LC/MS/MS or ELISA
  • Global locations in New Jersey and China. 80+ instruments. 200+ validated assays
  • Plasma and urine sample assay of parent and key analytes in all phases of clinical and non-clinical development using single or multiple analyte assay methods
  • Fully GLP-compliant, non-clinical TK, non-GLP PK support or higher throughput Discovery level analysis

Metabolite Monitoring and Quantitation

  • Hot (14C or 3H) or cold samples from in-vitro, non-clinical ADME, clinical AME or cold PK studies
  • Metabolite radioprofiling, characterization, and structure identification utilizing specially designed LC/MS/MS systems, including Thermo Q Exactive Plus. LTQ Orbitrap™ combined with on-line or off-line detectors such as PDA and RAM
  • Radioprofiling with highly sensitive Topcount® and v.ARC™ Dynamic Flow radioactivity detectors
  • Pharmacokinetic evaluation of active metabolites in all phases of clinical and non-clinical development using LC/MS methods combined with semi-quantitative radioprofiling and NMR
  • MIST semi-quantitation from multi-dose clinical and non-clinical samples
  • Isolation and purification and 1-D NMR qualification of metabolites to be used as "in matrix" reference standards
  • Bulk metabolite isolation and purification with structural elucidation (1-D and 2-D 1H and 13C NMR)