Safety Assessment Services

Whether you are working on an innovative small molecule or an advanced biologic drug candidate, you can rely on the Safety Assessment Team of WuXi AppTec to use its proven expertise to develop a program that meets your own specific needs. One that is fully compliant with U.S. Food and Drug Administration (FDA), Organization for Economic Co-operation and Development (OECD) and the National Medical Products Administration (NMPA) Good Laboratory Practice (GLP) requirements. Your studies are conducted in a fully AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) accredited state-of-the-art facility and overseen by Testing Facility Management (TFM) with over 170 years of combined experience. The studies we’ve conducted have supported more than 600 Investigation New Drug (IND) applications and New Drug Applications (NDA) worldwide.

A fundamental principal of WuXi AppTec is to ultimately see your success as our biggest achievement. We are passionate about your program and understand the importance of meeting drug development milestones, giving you the most robust data and keeping your drug on the path to success. As your scientific and business partner, we will go above and beyond to ensure we complete your study as planned, providing you with a quality product on time, every time.

Track Record of Success

For nearly a decade, the Toxicology Team has provided a full-scale testing platform for clients at all stages of drug development. Leveraging the translational expertise of our diverse team of scientists, we have completed thousands of discovery, IND- and NDA-enabling studies for our global clients, while maintaining a nearly perfect record of on-time delivery.

Whether you need a four week rodent study to support an IND filing or a two year carcinogenicity study for an NDA, all of your safety assessment studies will be conducted in our ultra-modern 580,000 square foot facility comprising 220 animal rooms.

 

Countries Supported

Safety Assessment Staff

IND/NDA Packages Submitted Globally

Safety Assessment Studies conducted/ Year

%

On-Time Data and Report Delivery

By building a service entirely around your needs, we can provide a single program that will include one Standard for Exchange of Nonclinical Data (SEND) compliant master dataset, reduce test sample volumes and minimize the need for potential duplicative animal testing. We also design each program with the flexibility needed to adjust to changing timelines, while still securing your original deadlines. This model has consistently performed and maintained a 99% on time delivery of audited draft reports.

To give you complete visibility of the testing process, our monitoring systems were carefully designed to provide real time data access and regular communication with your dedicated Project Managers. By working closely together, we pool our joint knowledge and scientific expertise to spot potential risk factors and avoid delays before they can adversely impact timelines.

WuXi AppTec’s safety assessment facility in Suzhou, China, currently has over 600 staff and are also among the most qualified globally, both in education and experience in the field of drug development. Approximately 25% have graduate degrees, and the Senior Management team has gained significant experience internationally. Our Study Directors hold certifications from Diplomate of the American Board of Toxicology (DABT) and the European Registered Toxicologist (ERT) and bring a wealth of knowledge to every program. The Toxicology Team has conducted over 5,000 safety assessment studies since January 2011.

Service & Quality

Our Safety Assessment services are fully integrated within our comprehensive testing platform, providing customers with the multidisciplinary expertise and experience that is inherent to WuXi AppTec. This approach not only yields significant time and cost savings, but the institutional knowledge gained when handling your project in its entirety is invaluable in terms of the data and insight we are able to provide. Our commitment to world-class quality has been validated by both government agencies and numerous clients around the world.

Laboratory Analytical Sciences

Our team of scientists can seamlessly manage the evaluation of your compound through preclinical toxicokinetic (TK) and pharmacokinetic (PK) analysis supporting your programs toxicology studies, all within WuXi AppTec.

Analytical chemistry

  • Method transfer, development, validation and sample analysis
  • Small molecule
  • Large molecule

Bioanalysis

  • Method transfer, development, validation and sample analysis
  • TK/PK analysis
  • TK modelling
  • Immunology
    • Immunohistochemistry
    • Flow cytometry
    • Immunochemistry
    • Tissue cross reactivity (rat, dog, non-human primate, human)
    • Immunogenicity or ADA assay
    • Neutralizing and non-neutralizing antibody reagent manufacturing
    • Biomarkers