Objective

We have developed human in-vitro skin explant assays to assess the safety, efficacy and dose response to biopharmaceuticals, cosmetic and chemicals from a hypersensitivity perspective. The Skimune™ MAb assay tests biologics using human blood and non-artificial autologous human skin from a healthy donor to assess for histopathological damage to skin tissue. This can also be correlated to T cell proliferation and IFN-ƴ release screening assays which give a predictive read out for adverse immune reactions. This skin explant assay can be modified to test immunomodulatory biologics, biosimilars, antibody-drug conjugates, chemicals and cosmetics as well as to investigate mode of action. As advancement in our services we have also developed a full thickness 3D autologous human skin equivalent model Skimune™-3D which can be used as an in-vitro testing platform for toxicology studies. Skimune can provide information on the safety, efficacy and dose response of biopharmaceuticals including small molecule drugs, mabs,biosimilars AB drug conjugates, as well as predicting potential adverse immune reactions prior to phase 1 clinical trials.