The safety and efficiency of drugs are critical for their clinical success. Many drug candidates have been found causing adverse effects on the structure and/or function of the immune system, or on other systems as a result of immune system dysfunction. Immunotoxic substances, such as chemicals, pesticides and drugs, may lead to adverse effects to the immune system, these undesirable effects include the following ones:
✓ Increased susceptibility to infections or tumors as a result of the humoral and/or cellular immunity being compromised (immunosuppression)
✓ Autoimmune diseases or chronic inflammation
✓ Stimulation of the immune system, which may result in allergies
Assessment of potential adverse effects on the immune system is an important component of the overall safety evaluation of new drugs and biotechnology products. Recent guidelines from the EMEA, and FDA/CDER emphasize the needs to assess the immunotoxic effects during the pre-clinical phase.
Creative Animodel offers assessment service to screen the therapeutic drug candidates for their potential immunotoxicity. We have been dedicated in immunotoxicity evaluation for years and have extensive technical experience in this filed, with our state-of-the-art technology, we can assist our client in identifying the immunologic characterization of the new drugs at pre-clinical stage based on drug's mechanism and potential clinical use.
Immunotoxicity can normally be assessed using in vitro and in vivo assays of immune function. The following in vivo assays are currently available at Creative Animodel:
✓ Protein toxicokinetics
✓ Anti-drug antibody monitoring
✓ Immunogenicity testing
✓ Hypersensitivity testing
✓ Host resistance assays
✓ Inflammation and asthma models
✓ Innate immunity
✓ Developmental immunotoxicity testing
Compare with the in vitro assay, tests in the appropriate animal model will normally provide a more accurate picture of the immune response competence and a more relevant indication of the immunotoxic potential. Immunotoxicity assessment at the earliest possible stage may have important implications in drug development and resulting in a safe and cost-effective biologic.
Creative Animodel provides a suite of services for understanding immunotoxicity. These assays can be used together as part of your immunotoxicity risk evaluation program, or as stand-alone assays. In addition, in combination with our in vitro immunotoxicity system, we can provide clients a fast and reliable evidence of the immunotoxic characterization of the drug candidate.