Pre-Clinical Considerations in the Assessment of Immunogenicity for Protein Therapeutics
Pre-Clinical Considerations in the Assessment of Immunogenicity for Protein Therapeutics
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DOI：
10.2174/157488610792246000
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发表时间：
2010-01-01
影响因子：
1.5
通讯作者：
Carr, Francis J.
中科院分区：
文献类型：
--
作者：
Baker, Matthew P.;Carr, Francis J.
蛋白质治疗剂提供了明显优于其他类别的药物的优势，主要是由于高水平的目标特异性和一般低毒性。然而，一些蛋白质治疗剂在患者中诱导不期望的免疫应答时遇到了问题。这种免疫原性可产生多效性效应，包括产生通常针对治疗剂的高亲和力B细胞介导的体液应答。关于临床免疫原性的主要原因，意见不一，因此，这一领域一直是许多研究的主题。由于这种强烈的活性而出现的一件事是临床前模型的开发，该模型可以在人类施用之前提供对新型蛋白质治疗剂的免疫原性潜力的一定水平的预测。
Protein therapeutics offer distinct advantages over other classes of drugs largely due to the high level of target specificity and generally low toxicity. Problems have, however, been encountered with some protein therapeutics inducing undesirable immune responses in patients. This immunogenicity can produce pleiotropic effects including the development of a high affinity B cell-mediated humoral response that is often directed against the therapeutic. Opinions are divided as to the principal causes of clinical immunogenicity and, as a result, this area has been the subject of much research. One thing that has emerged as a result of this intense activity is the development of pre-clinical models that can provide a level of prediction of the immunogenic potential of novel protein therapeutics before administration in man.