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对于生物类似药的开发,免疫性评估所需的变化

Johann Poetzl¹

¹Clinical Development Biopharmaceuticals, Hexal AG (A Sandoz company), Holzkirchen, Germany.

|February 4, 2025

概括

免疫性评估的进步为生物类似物开发提供了新的策略. 将免疫性风险评估纳入许可申请,有助于监管审查,并证明生物相似性.

科学领域:

生物制药产品生物制药产品
免疫学免疫学免疫学
监管科学监管科学

背景情况:

最近分析技术和免疫性知识的进步对生物制药的发展产生了重大影响.
不断变化的景观为生物相似开发提供了新的机会,重点是展示分子相似性.

研究的目的:

探索 in silico 和 in vitro 免疫原性评估工具对生物类似物开发的有用性.
建议在生物类似药物许可申请中包括免疫性风险评估 (ISI).
突出了完善免疫性测试的操作考虑.

主要方法:

在和体外免疫性评估工具的评估.
对生物类似药物的监管文件要求的审查.
在免疫性测试中考虑操作方面的考虑.

主要成果:

目前正在评估in silico和in vitro工具在生物类似物免疫性评估中的作用.
建议通过将免疫原性数据置于背景中来支持卫生当局审查的ISI.
像信号噪声比和单酸盐分析这样的操作因素对于测试很重要.

结论:

整合先进的免疫性评估,包括ISI,对于强大的生物类似物开发至关重要.
这些工具的战略应用有助于监管部门的批准,并证明生物相似性.
完善测试方法对于准确的免疫性特征是必不可少的.

关键词:

生物类药物是生物类药物.免疫性风险评估免疫性风险评估在 silico 和 in vitro 免疫原性评估.免疫性综合总结免疫性综合总结信号与噪声的比率.单个样本分析分析单个样本分析.

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