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

  • Method development and validation - LC/MS/MS, ligand binding assay
  • Sample analysis - LC/MS/MS, and ligand binding assay
  • Synthesis of reference standard and labled IS - LC/MS/MS
  • Immunogenicity - ligand binding assay

 

Discovery Bioanalytical Services

  • Rapid Turnaround Quantitative Analysis
    Integrated with DMPK services
  • Metabolite Identification
    Profiling, structure elucidation, and synthesizing authentic reference standard

Service Features

  • Studies
    Preclinical/Clinical PK and PD
    Toxicokinetic
    Immunogenicity
  • Instrumentation
    API 4000/5000 MS
    UPLC
    MSD Sector Imager 6000
    Molecule Devices M2/M5 reader
    Luminex 200
  • Capacity and Experience
    13 established clients
    15,750 sq. ft.
    120 staffs
    Numerous studies submitted to FDA and SFDA
  • 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

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