作者: H.G. Haggerty , K.D. Price , J.M. Shenton
DOI: 10.1016/B978-0-08-046884-6.00629-1
关键词: Biopharmaceutical 、 Immune system 、 Immunosuppression 、 Immunogenicity 、 Immunosurveillance 、 Immunity 、 Disease 、 Biology 、 Immunology 、 Immunotoxicology
摘要: A number of biopharmaceuticals that are marketed or in development intentionally immunomodulatory they directly suppress stimulate the immune system, while others indirectly, and sometimes unintentionally, affect system function. Regardless whether immunomodulation is intentional not, it may result adverse consequences. Molecules downmodulate responses protect against consequences a disease, but also have potential to how body protects itself infection malignancies by impairing immunosurveillance, agents help fight cancer can autoimmunity. The testing biopharmaceutical should include specialized evaluation possible immunotoxicity based on an understanding type (monoclonal antibody, fusion protein, recombinant human cytokine, etc.) its expected mechanism action. battery vitro vivo tests for evaluating available, knowledge target essential determine appropriate paradigm. Testing routine assays assess general status be incorporated into required toxicology studies stand-alone targeted specific components immunity function (e.g., susceptibility cancer). intended action, assessment immunogenicity always included due possibility eliciting response animals and/or humans, which safety concerns such as loss activity exposure, immune-complex neutralization endogenous proteins. Characterizing critical risk patients immunotoxicities resulting from immunogenicity, immunosuppression, immunostimulation.