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Evaluating the potential side effects of human pharmaceuticals on the immune system should be incorporated into standard drug development process. Toxicity to the immune system includes inhibition or enhancement of the immune response. Inhibiting the immune response can result in a decrease in host resistance to infectious agents or tumor cells, while enhanced immune response can exacerbate autoimmune diseases or allergies. Currently, the assessment of immunotoxic effects depends on different animal models. With a few exceptions, the immune system of humans and experimental animals are very similar. Most drugs that inhibit the immune system in humans produce similar results in rodents, and the mechanisms for immunosuppressive action are similar.

Creative Bioarray has validated and implemented a series of standardized immunotoxicity testing protocols based on experimental animal models, which are fully compliant with international guidelines and recommendations. These methods are described below:

Humoral Immunity

  • Serum globulin levels and albumin-to-globulin (A/G) ratios
  • Immunoglobulin isotype distribution of IgM, IgG, IgA and IgE
  • Immunochemical assay of serum cytokines
  • Total haemolytic complement activity and components of complement
  • Serum auto-antibody screening and deposition of immunoglobulins

Cellular Immunity

  • Immunostaining and flow-cytometric analysis of B cells, T cells and T cell subsets
  • Mitogenic stimulation assays for B and T cells
  • Natural killer (NK) cell activity
  • Macrophage and neutrophil function assays


  • Total leukocyte counts and absolute differential leukocyte counts
  • Lymphoid organ weight, body weight and temperature measurement
  • Gross pathology and histopathology analysis of spleen, thymus, lymph nodes, Peyer’s patches and bone marrow

Preclinical immunotoxicology studies can help identify negative effects or unpredictable behaviors so they can be corrected and prevented. At Creative Bioarray, our in-house processes are designed to guarantee maximum efficiency and to ensure you receive high-quality reports within a competitive timeframe. Please feel free to contact us, if you have any needs.

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