Applicability of Standard Immunological Methods for Nanoparticle Evaluation and Challenges Specific to Nanoparticle Characterization

Immunotoxicological evaluation of new drug candidates includes studies on both immunosuppression and immunostimulation, and is applicable to nanomaterials intended for use as drug candidates and/or drug delivery platforms. Short-term in vitro assays are being developed to allow for quick evaluation of nanoparticles' biocompatibility. The in vitro immunotoxicity assay cascade includes the following methods: analysis of plasma protein binding by two-dimensianol polyacrylamide gel electrophoresis (PAGE), hemolysis, platelet aggregation, coagulation, complement activation, colony forming unit-granulocyte macrophage (CFU-GM), leukocyte proliferation, phagocytosis, cytokine secretion by macrophages, chemotaxis, oxidative burst, and evaluation of cytotoxic activity of NK cells.147 In addition to these methods, our in vitro tests include sterility assessment based on pyrogen contamination test (L-amebocyte lysate (LAL) assay) and evaluation of microbiological contamination. The assay cascade is based on several regulatory documents recommended buy the FDA for immunotoxicological evaluation of new investigational drugs, medical devices, and biotechnology, derived pharmaceuticals,148-152 as well as on ASTM and ISO standards developed for characterization of blood contact properties of medical devices.153-155 The aim of the in vitro immunoassay cascade is to provide quick evaluation of nanomaterials of interest prior to initiation of more thorough in vivo studies. Challenges specific for immunotoxicity assessment of nanoparticulate materials are summarized below.

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