U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

extractables and leachables

Extractables / Leachables Studies for Medical Devices & Combination Products


  • Materials Analysis – identification of materials, processing aids and additives
  • Process Development – simulated-use extractions, comparative materials studies


  • Extractables – detection and quantitation of analytes presenting potential risk
  • Leachables – target analyte plans; method validations; leachable studies to quantitate
    migrated analytes; toxicology and biologic evaluations

Lot Release

  • Target Analysis – quantitation of specific compounds, quality control, residuals evaluation
  • Failure Analysis – identification of unknowns and contaminants

Program Features

  • State-of-the-art equipment
  • Experienced staff
  • Qualified and validated methods available
  • R&D, GLP and GMP services
  • Fully customizable test programs
  • Risk assessments with on-site toxicologists and chemists
  • Regulatory and consulting services available
  • Integrated services providing greater efficiency and cost effectiveness

Linking Your Chemistry and Biocompatibility

WuXi AppTec experts can help you link your chemistry to your biocompatibility data in a risk assessment evaluation. We have many years of experience in performing comprehensive biocompatibility services that meet worldwide regulatory requirements. So we can perform the in-vitro and in-vivo assays that address your product and submission goals, and tailor the design of the testing program to find answers to questions raised from your materials characterization.

Click here for more information on our biocompatibility testing services.

For more details on available testing services, click here to access the Catalog of Services for Devices and Combination Products.