Biologic Drug Immunogenicity

The MIMIC® System can detect differences in the immunogenicity of biologic drugs. Biologic drugs, such as monoclonal antibodies, may provoke an immune response in the human body. Even small differences in the manufacturing process for these biologic drugs can significantly change the immunogenicity profile. In many cases, the immune response can neutralize the therapeutic benefit of the drug. Rarely, a biologic drug can cause an autoimmune response which becomes life threatening.

For this MIMIC® application, the Peripheral Tissue Equivalent (PTE) module alone is used to model innate immune responses. Adaptive immune responses are modeled with the Lymphoid Tissue Equivalent (LTE) module paired with the PTE module. The drug candidate is administered to the PTE module. After the antigen-presenting cells have become activated, the liquid containing the activated cells is removed from the PTE module and placed into the LTE module. In the LTE module, the antigen-presenting cells induce antigen-specific cell expansion and cytokine production for T cells, and expansion, differentiation, and production of antigen-specific antibodies for B cells. The results are measured with standard tests, including cytokine profiles, cell proliferation, cell phenotype analysis, and antibody levels.

Drug developers can use the MIMIC® System at all stages in the research, development, and manufacture of a biologic drug to monitor immunogenicity.

  • Early in the research and development process, researchers can select for molecules that have low immunogenicity.
  • Later, as the manufacturing process changes to increase the amount of product, the MIMIC® System can ensure that the different process has not changed the immunogenicity of the product.
  • Finally, the MIMIC® System can test batches of product before release into the market, as a quality control test.