Immune Checkpoint and Immunostimulatory Reporter Bioassays to Advance the Development of Therapeutic Antibodies in Immunotherapy Research Programs

Immunomodulatory biologics, which elicit their therapeutic effects by inducing, inhibiting, or modulating immune responses, have shown therapeutic utility in a variety of clinical conditions including cancer and autoimmune disease. As a result, biologics therapeutics, and monoclonal antibodies (mAb) in particular, are a dominant and increasing focus of pharmaceutical pipelines. However, due to their structural and biological complexity, mAb biologics and biosimilars require unique functional and analytical tools for development and characterization. We have developed a suite of cell and reporter-based bioassays to advance the development and commercialization of mAb biologics. Specifically, we have developed cell-based bioassays in “thaw-and-use” format for the following Immune Checkpoint and Immunostimulatory receptor targets: PD-1/PD-L1, CTLA-4, LAG-3 GITR, 4-1BB, CD40, OX40 T Cell Activation These reporter-based bioassays offer high specificity, sensitivity, and reproducibility, and demonstrate the performance required for use in antibody screening, potency determination, and stability studies.