Can the Humanized Mouse Model Inform Immunogenicity Risk Assessment? (S03-4)

Humanized mice represent a novel animal model that enables assessment of the human immune system inside of a mouse.  They have been shown to have utility in evaluation of adverse events such as cytokine release syndrome, but to date, have not been thoroughly evaluated for their ability to assess immunogenicity risk.  This presentation will share results from a recent study that evaluated bone marrow-liver-thymus (BLT)- and CD34 humanized mice, and their ability to produce adaptive immune responses to biological drug products known to be immunogenic in patients.