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关于当前行业实践的智商调查结果-第1部分:免疫性风险评估

Christine Grimaldi¹, Susan Richards², Daniel Baltrukonis³

¹Bioanlytical Sciences, Regeneron, Inc, Tarrytown, New York, USA.

Clinical pharmacology and therapeutics

|January 29, 2025

概括

免疫性风险评估 (IRA) 是药物开发的关键部分. 虽然公司已经建立了IRA过程,特别是单克隆抗体,但对于新型治疗方式需要更多的经验.

科学领域:

生物制药开发生物制药开发
药物安全和风险评估
免疫学免疫学免疫学

背景情况:

卫生当局越来越多地期望在药物开发中进行免疫性风险评估 (IRA).
IRA涉及评估产品和患者因素,以预测生物治疗药物的免疫潜力和计划行动.

研究的目的:

调查目前在制药/生物技术行业进行IRA和生物分析的做法.
了解公司如何在各种药物模式中对免疫性风险评估进行评估.

主要方法:

由IQ联盟的免疫性工作组进行了一项调查.
从19家IQ成员公司收集了答案,涵盖了包括单克隆抗体和新模式在内的多种类型的药物.

主要成果:

大多数公司已经定义了IRA流程,承认随着开发的进展需要灵活性.
在IRA实施时间表,临床前数据使用,计算方法和与临床计划集成方面存在差异.
对单克隆抗体有丰富的经验,但新的模式需要进一步开发IRA.

结论:

公司通常已经建立了IRA流程,对其动态性质达成共识.
对于单克隆抗体,已有大量的经验,但新的治疗方式对全面的免疫性风险评估构成持续的挑战.

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An antigen is any substance the immune system identifies as foreign and potentially harmful to the body, prompting an immune response. Antigens have two functional properties: immunogenicity and reactivity. Immunogenicity is the ability of an antigen to stimulate a specific immune response. At the same time, reactivity describes the antigen's ability to react with the cells and antibodies produced in response to it.
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