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/SFDA GLP
• ICH/SFDA GCP
• 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