ABSTRACT
INTRODUCTION Immunological evaluation includes both immunosuppression and immunostimulation and is applicable to nanoparticles intended to be used as drug candidates and/or as drug delivery platforms. Short-term in vitro assays are developed for quick evaluation of biocompatibility of nanoparticles, which includes analysis of plasma protein binding by polyacrylamide gel electrophoresis (PAGE), hemolysis, platelet aggregation, coagulation, compliment activation, colony-forming unit-granulocyte macrophage (CFU-GM), leukocyte proliferation, phagocytosis, cytokine secretion by macrophages, chemotaxis, oxidative burst, and evaluation of cytotoxic activity of natural killer (NK) cells. In addition to these methods, in vitro test may also include sterility assessment and pyrogen contamination test by Limulus amebocyte lysate assay. These assay cascades are based on several regulatory documents recommended by the U.S. Food and Drug Administration for immunotoxicological evaluation of new investigational drugs, medical devices, and biotechnology derived pharmaceuticals (1-5), as well as ASTM and ISO standards developed for characterization of blood contact properties of medical devises (6-8). Challenges for specific immunological assessment of nanoparticulate materials are summarized in this chapter.
