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• W4239864450 endingPage "851" @default.
• W4239864450 startingPage "826" @default.
• W4239864450 abstract "A number of biopharmaceuticals that are marketed or in development are intentionally immunomodulatory in that they directly suppress or stimulate the immune system, while others indirectly, and sometimes unintentionally, affect immune system function. Regardless of whether immunomodulation is intentional or not, it may result in adverse consequences. Molecules that downmodulate immune responses may protect against the adverse consequences of a disease, but they also have the potential to affect how the body protects itself against infection and malignancies by impairing immunosurveillance, while agents that stimulate the immune system to help fight infection or cancer can result in autoimmunity. The testing of a biopharmaceutical should include specialized evaluation of possible immunotoxicity based on an understanding of the type of biopharmaceutical (monoclonal antibody, fusion protein, recombinant human cytokine, etc.) and its expected mechanism of action. A battery of in vitro and in vivo tests for evaluating immunotoxicity is available, and knowledge of the target and type of biopharmaceutical is essential to determine an appropriate testing paradigm. Testing may include routine or specialized assays to assess general immune status that can be incorporated into required toxicology studies or stand-alone studies and targeted assays that assess specific components of immunity or immune function (e.g., susceptibility to infection or cancer). Regardless of the intended mechanism of action, an assessment of immunogenicity should always be included due to the possibility of the biopharmaceutical eliciting an immune response in animals and/or humans, which may result in safety concerns such as loss of activity or exposure, immune-complex disease, or neutralization of endogenous proteins. Characterizing the potential immunotoxicity of a biopharmaceutical is critical for understanding the potential risk to patients of immunotoxicities resulting from immunogenicity, immunosuppression, or immunostimulation." @default.
• W4239864450 created "2022-05-12" @default.
• W4239864450 creator A5023399618 @default.
• W4239864450 creator A5025078776 @default.
• W4239864450 creator A5035224067 @default.
• W4239864450 date "2018-01-01" @default.
• W4239864450 modified "2023-09-25" @default.
• W4239864450 title "Immunotoxicology of Biopharmaceutics" @default.
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