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Updated: Jun 12, 2025

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具有转化免疫原性的治疗蛋白质的免疫原性风险缓解,分析表征和监管洞察力

Sadiqua Shadbar¹, Sathy Balu Iyer², Jared Auclair³

¹Translational Medicine, Elektrofi Inc., Boston, MA 02210, USA; Department of Chemistry and Chemical Biology, College of Science, Northeastern University, Boston, MA 02115, USA.

Journal of pharmaceutical sciences

|June 10, 2025

概括

治疗性蛋白质免疫性是一个主要的挑战. 本综述详细介绍了影响免疫反应的因素以及评估和减轻更安全生物制药风险的策略.

科学领域:

生物制药开发生物制药开发
免疫学免疫学免疫学
药品安全药品安全

背景情况:

治疗性蛋白质的免疫性是生物制药开发中的一个重大障碍,导致临床失败.
免疫反应可能导致抗药抗体 (ADA) 发育,注射部位反应 (ISR) 和疼痛 (ISP).

研究的目的:

审查影响治疗蛋白质免疫性因素.
讨论评估免疫性风险的策略和工具.
为蛋白质治疗药物的综合免疫性风险评估提供信息.

主要方法:

影响因素的分类:与患者相关,与产品相关,与管理相关.
免疫反应中介影响的概述 (ADA,ISR,ISP).
评估工具的讨论:in silico,in vitro,ex vivo,in vivo和临床试验,以及分析特征.

主要成果:

确定了影响治疗蛋白质免疫性的主要因素.
介绍了一系列免疫性评估的工具和策略.
强调了评估工具的综合,相应阶段的使用的重要性.

结论:

综合免疫性测试策略对于开发安全有效的蛋白质疗法至关重要.
尽量减少免疫性风险需要采用综合方法,考虑各种因素和评估方法.
了解监管指导和财团努力有助于制定风险评估策略.

关键词:

分析性表征分析性表征抗体 (s) 是一种抗体.生物制药特征的表征过敏症是一种过敏症.免疫复合体 (s)免疫反应的作用是 ()免疫性免疫性免疫性在体外模型 (in vitro模型)蛋白质聚合蛋白质的聚合.监管科学是一种监管科学.

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