Analytical and Bioanalytical Services

Fully Compliant with US FDA, OECD, Chinese SFDA GLP Requirements WuXi AppTec has an understanding of the unique expectations of Analytical and Bioanalytical services. A dedicated and knowledgeable team is able to meet our clients need for accurate, high quality data analysis on tight budgets. Our platforms and protocols provide extensive GLP and non-GLP services for both small and large molecules.

GLP Bioanalytical Services:

  • US FDA Audit completed with no 483 observations
  • Method development and validation – LC-MS/MS, ligand binding assay
  • High throughput sample analysis – LC-MS/MS, ligand binding assay
  • PK/TK/PD analysis for pre-clinical and clinical samples
  • Synthesis of reference standard and labeled internal standards – LC-MS/MS
  • Immunogenicity - ligand binding assay and cell-based assay
  • Generic drug BE studies – pilot and pivotal

Discovery Bioanalytical Services:

  • Rapid turnaround quantitative analysis; Integrated with DMPK services
  • Metabolite Identification; profiling, structure elucidation, and synthesizing authentic reference standard Quality Standards
  • FDA 21 CFR – Part 11 and Part 58

Pharmacy and GLP Analytical Chemistry Services:

  • Dedicated Pharmacy Laboratory

    • Separate rooms for individual formulation preparation
    • Separate rooms for individual vehicle preparation
    • Secure and separate storage area for test articles and vehicle/control articles
  • Analytical Chemistry Laboratory

    • Analysis done in-house for over 90% of GLP studies
    • Agilent 1200 HPLC systems
    • GLP-validated Chemstore/Chemstation software
  • Fully GLP Compliant

    • Method development, validation, sample analysis