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作 者:Daohong Chen
机构地区:[1]Research Institute,Changshan Biochemical Pharmaceutical,Shijiazhuang,Hebei 050800,China.
出 处:《The Journal of Biomedical Research》2024年第1期17-23,共7页生物医学研究杂志(英文版)
摘 要:Immune-related adverse events(irAEs)represent an increasingly concerning challenge in the assessment of biopharmaceutical products.In contrast to historically rare allergic reactions associated with small chemical drugs,contemporary biotherapeutics exhibit a significantly higher morbidity of irAEs,because of their complex structure and comprehensive mechanisms of action.While the immunogenicity of protein-based compounds is associated with the induction of anti-drug antibodies,the pathogenesis of irAEs in advanced biologics,such as cell and gene therapy,remains to be further delineated.In the current study,I present an updated profile regarding the untoward immune effects of medications,covering various material categories systematically,with the underlying mechanisms to inspire risk mitigation in biopharmaceutical development and application.
关 键 词:IMMUNOTOXICOLOGY immune-related adverse events anti-drug antibody
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