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合成类药物及其杂质的免疫性风险评估

Anne S De Groot¹, Brian J Roberts², Aimee Mattei²

¹EpiVax, 188 Valley Street, Suite 424, Providence, RI, USA; University of Georgia, Center for Vaccines and Immunology, Athens, GA USA.

Drug discovery today

|July 19, 2023

概括

通用类药物提供治疗益处,但杂质可以触发免疫反应. 本审查概述了评估类药物免疫原性的框架,这对于仿制药和新药开发和监管审查至关重要.

科学领域:

药理学药理学是指药理学的学科.
免疫学免疫学免疫学
药物开发药物开发

背景情况:

类药物是重要的治疗药物,具有众多的应用.
现在有几种类药物已经脱离专利,导致通用药的开发.
监管机构正在探索加速通用药物获取的途径.

研究的目的:

审查如何类药物杂质可以导致免疫性.
提出一个框架来评估产品中的免疫性风险.
为通用和新型类药物的监管策略提供信息.

主要方法:

关于类药物杂质和免疫原性的文献综述.
对仿制类药物的监管考虑的分析,包括缩写新药申请 (ANDA) 途径.
免疫原性风险评估的框架开发.

主要成果:

类药物杂质可以引入T细胞表位,可能导致不良的免疫反应.
拟议的框架涉及对各种生物活性的免疫性风险评估.
了解杂质驱动的免疫性对于监管批准至关重要.

结论:

评估类药物杂质对于确保安全性和有效性至关重要.
描述的框架支持对仿制药和新疗法的风险评估.
积极的免疫性评估有助于监管合规和患者安全.

关键词:

在HLA结合过程中.对T细胞的测定.T细胞表皮图是T细胞表皮图.计算免疫学计算免疫学仿制药是一般的药物.免疫性免疫性免疫性污染物是一种杂质.这是一种类药物药物.

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