DEVELOPMENT OF NOVEL ANTI-CANCER BIOTHERAPEUTICS: FROM THE BENCH TO THE CLINIC

Cytokines have a potent therapeutic activity in malignances. However, their use in cancer immunotherapy is limited by their inability to determine optimal concentrations into tumor sites due to dose-limiting systematic toxicities. Immunocytokines represent a novel class of biotherapeutics that combine the antibodies ability to localize on tumor microenvironment with the immunomodulatory properties of cytokines. Numerous immunocytokines have been currently investigated in pre-clinical e clinical studies. The authority such as Food e Drug Administration and European Medicines Agency mandatory required specific bioanalysis for medicinal product development. Bioanalysis has an important role in pharmaceutical industries in order to evaluate the appropriate and safe dose of biotherapeutics during drugs development. This thesis provides an overview of methods used to investigate pharmacokinetic, toxicokinetic and development of anti-drug antibody in pre-clinical and clinical samples