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首页> 外文期刊>Expert opinion on biological therapy >Immunogenicity screening in protein drug development.
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Immunogenicity screening in protein drug development.

机译：蛋白药物开发中的免疫原性筛选。

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摘要

Most therapeutic proteins in clinical trials or on the market are, to a variable extent, immunogenic. Formation of antidrug antibodies poses a risk that should be assessed during drug development, as it possibly compromises drug safety and alters pharmacokinetics. The generation of these antibodies is critically dependent on the presence of T helper cell epitopes, which have classically been identified by in vitro methods using blood cells from human donors. As a novel development, in silico methods that identify T cell epitopes have been coming on line. These methods are relatively inexpensive and allow the mapping of epitopes from virtually all human leukocyte antigen molecules derived from a wide genetic background. In vitro assays remain important, but guided by in silico data they can focus on selected peptides and human leukocyte antigen haplotypes, thereby significantly reducing time and cost.
机译：临床试验或市场上的大多数治疗性蛋白质在不同程度上具有免疫原性。抗药物抗体的形成带来了在药物开发过程中应评估的风险，因为它可能会损害药物安全性并改变药代动力学。这些抗体的产生关键取决于T辅助细胞表位的存在，传统上已经通过体外方法使用人类供体的血细胞鉴定出了T辅助细胞表位。作为一种新的发展，鉴定T细胞表位的计算机方法已经开始流行。这些方法相对便宜，并且允许从实际上来自广泛遗传背景的所有人类白细胞抗原分子中映射表位。体外测定仍然很重要，但是在计算机数据的指导下，它们可以专注于所选的肽和人白细胞抗原单倍型，从而显着减少时间和成本。

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