As a screening procedure to detect immunologic effects, different parameters are discussed. These criteria include growth, weight and histology of lymphoid and endocrine organs, haematology, as well as serum immunoglobulin concentrations which can be quantified using the enzyme-linked immunosorbent assay (ELISA). Secondly, different function tests are discussed to assess in the rat the cell-mediated immunity, the humoral immunity and the phagocytosis by macrophages. Most therapeutic monoclonal antibodies (mAbs) licensed for human use or in clinical development are indicated for treatment of patients with cancer and inflammatory/autoimmune disease, and as such are designed to directly interact with the immune system. A major hurdle for the development and early clinical investigation of many of these immunomodulatory mAbs is their inherent risk for adverse immune-mediated drug reactions in humans such as infusion reactions, cytokine storms, immunosuppression and autoimmunity. To assess the risk potential of HSA derived from Oryza sativa (OsrHSA) before a First-in-human (FIH) trial, we compared OsrHSA and plasma-derived HSA (pHSA), evaluating the potential for an immune reaction and toxicity using human peripheral blood mononuclear cells (PBMCs). The results indicated that neither OsrHSA nor pHSA stimulated T cell proliferation at 1x and 5x dosages. We also found no significant differences in the profiles of the CD4+ and CD8+ T cell subsets between OsrHSA- and pHSA-treated cells. Furthermore, the results showed that there were no significant differences between OsrHSA and pHSA in the production of cytokines such as interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α), interleukin (IL)-10 and IL-4. Our results demonstrated that OsrHSA has equivalent immunotoxicity to pHSA when using the PBMC model. Moreover, this ex vivo system could provide an alternative approach to predict potential risks in novel biopharmaceutical development.

Many of the immunomodulatory effects of mAbs are desirable and intended immunopharmacology that is required for clinical efficacy. However, activation or suppression/depletion of non-target immune cells and mediators, or permanent non-reversible changes to immune target cells/pathways, or any unintended sequelae of the intended pharmacology. Non-clinical safety testing programs for mAbs must be rationally-designed with a strong scientific understanding of the product, including its method of manufacture, purity, sequence, structure and class/isotype, pharmacological and immunological effects, the biology of the target and intended clinical use, e.g., indication, patient population and dosing regimen.

Papaya is an important fruit that provides a variety of vitamins with nutritional value and also holds some pharmacological properties, including immunomodulation. Genetically modified (GM) papaya plants resistant to Papaya ring spot virus (PRSV) infection have been generated by cloning the coat protein gene of the PRSV which can be used as a valuable strategy to fight PRSV infection and to increase papaya production. Human serum albumin (HSA) is extensively used in clinics to treat a variety of diseases, such as hypoproteinemia, hemorrhagic shock, serious burn injuries, cirrhotic ascites and foetal erythroblastosis. To address supply shortages and high safety risks from limited human donors, we recently developed recombinant technology to produce HSA from rice endosperm.

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Ruby Katherine

Managing Editor

Journal of Nanoscience & Nanotechnology Research