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    Toxicology Services

    Whether you are working on an advanced biologic or an innovative small molecule drug, you can rely on The Toxicology Unit of the WuXi AppTec Laboratory Testing Division to use its proven expertise to develop a study that meets your own specific needs. One that will be fully compliant with FDA, OECD and NMPA GLP requirements, conducted in a fully AAALAC accredited state-of-the-art facility and overseen by staff with over 170 years of combined experience. To date, our studies have been used to support almost 600 IND/NDAs worldwide.

    These include post-discovery bioanalysis work, in which our scientists can seamlessly carry your compound through preclinical PK and toxicology, all within the Bioanalytical Services Unit. Building on knowledge gained during previous stages, we can significantly reduce timelines by eliminating the need to transfer a compound from one unit to another.

    By building a service entirely around your needs, we can provide a single program with one SEND compliant master dataset, reduce test sample volumes and minimize animal testing. We also design-in to each program the flexibility needed to adjust to changing timelines, while still securing your original deadlines – with over 99% of our draft reports delivered ahead of time.

    To give you complete visibility of the testing process, our monitoring systems have been carefully developed, providing real-time data access and constant communication with your dedicated Project Managers. By working so closely together, we pool our joint knowledge and scientific expertise to spot potential risk factors and avoid delays before they can ever begin impacting timelines.

    Whether you need a four-week rodent study for an IND or a two-year carcinogenicity study for an NDA, and whether you are a large multi-national or an emerging start-up – all your tests will be conducted in our ultra-modern 580,000 sq.ft facility comprising 220 animal rooms.

    Our 400+ staff are also amongst the most qualified globally, 23% have either PhDs or Masters degrees, and the senior team have all gained significant experience internationally, with our Study Directors (4 DABT/DSTA/ERT) bringing a wealth of knowledge to bear on every program. Between them, the Toxicology Unit has conducted over 4,000 safety assessment studies since January 2011.

    But most importantly, we see your success, as our biggest success. We understand the importance of meeting development milestones, giving you the most robust data and keeping your drug on the path to success. So, as your scientific and business partner, we will do whatever it takes to ensure we fully complete your chosen study in the fastest time possible.

    Service & Quality

    Toxicology is 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.

    A comprehensive menu of safety assessment services

    General Toxicology (rodent, rabbit, dog, NHP, minipig) • 14-day, 28-day, 13-week, 26/39-week
    Whether you need a four-week rodent study for an IND or a two-year carcinogenicity study for an NDA, and whether you are a large multi-national or an emerging startup – all your tests will be conducted in our ultra-modern 580,000sq.ft facility comprising 220 animal rooms. Furthermore, to ensure we minimize any variables, the air is HEPA filtered, computer controlled and constantly monitored.

    Safety Pharmacology
    Assessing the potential for toxicity across major therapeutic areas, including cardiovascular, gastrointestinal, renal and central nervous system is conducted using a full panel of in vivo and in vitro safety pharmacology studies in our world-class safety evaluation center.

    Genetic Toxicology
    Our genetic toxicologists and study directors can present you with rapid, high-quality data that can inform you of potential damage during subsequent stages of development and save you time and money for your program.

    Developmental & Reproductive Toxicology (DART)
    Offering a flexible study design is one of the many things that WuXi AppTec does best. When it comes time for your developmental and reproductive toxicology studies, WuXi AppTec can fully customize your designs to fit your individual needs, and yet, still be conducted within the regulatory guidelines.

    Ocular Toxicology
    Our Ophthalmologist-led services include: comparative ophthalmologic examination in varieties of toxicity studies, eye irritation, new ocular drug toxicity and toxicokinetics, pharmacodynamics and pharmacokinetics.

    Pre-clinical Development of Biologics
    Our preclinical studies for biologics are customized for each product and designed to generate meaningful results through the performance of a thorough scientific and regulatory-compliant program.

    Pre-clinical Immunology Services
    Our immunology services include immunohistochemistry, tissue cross-reactivity, immunochemistry, and vaccine development.

    Standard for Exchange of Nonclinical Data (SEND)
    We provide SEND data sets within 10 business days of the report date, two weeks faster than other laboratories.

    Supporting Laboratory Services

    Analytical chemistry
    Method transfer, development, validation and sample analysis

    Bioanalysis; TK modelling
    Method transfer, development, validation and sample analysis

    Immunology

  • Immunohistochemistry
  • Flow cytometry
  • Immunochemistry
  • Tissue cross reactivity (rat, dog, monkey, human)
  • Immunogenicity or ADA assay
  • Bioanalysis
  • Biomarkers