Immunotoxicity Predictions

We offer the MIMIC® System to test for potential immunotoxic effects of adjuvants, vaccines, drugs, biologics, nano and microparticles, cosmetics, and other products. For example, the MIMIC® System provides a platform for high-throughput TDAR (T Cell Dependent Antibody Response) and LLNA (Local Lymph Node Assay) tests. Although VaxDesign has not yet received regulatory acceptance of the MIMIC® System as a substitute for animal tests, we offer a way to reduce the use of animals in earlier stages of research and development while obtaining more predictive results from a human system.

In this application, we look for immunotoxic effects with the Peripheral Tissue Equivalent (PTE) module or Lymphoid Tissue Equivalent (LTE) module, or both, which are primed with a known activator of the immune system pathway of interest. The test compound may be present in the PTE module or LTE module prior to stimulation or added after stimulation. The results are measured with standard tests, including cytokine profiles, cell proliferation, cell phenotype analysis, and cell viability. Read our case studies for more details. We have used the Vascular PTE module to reproduce the known physiological effects of intravenous administration of biologics such as OKT3, Avastin®, and other monoclonal antibodies.

These studies may use as few as five donors to obtain preliminary results. However, to capture the full diversity of a target population, a study may use 20 or more donors.

The timeline for this type of study is 3-6 months, depending on the number of donors and the types of analysis desired by the customer. The cost of the study depends on the scope of the project and the analysis needed.