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开发和验证两种基于细胞的记者基因测试,用于确定重组人甲状腺激素药品的生物活性

Lyuyin Wang¹, Jing Gao², Kaixin Xu²

¹National Institutes for Food and Drug Control, No. 31, Huatuo Road, DaXing District, Beijing 102629, China.

Molecules (Basel, Switzerland)

|March 13, 2025

概括

开发了新的基于细胞的测试方法来测量甲状腺刺激激素 (TSH) 的生物活性,模拟药物开发和表征的体内效应. 这些经过验证的记者基因测定提供了对TSH药物效能和质量的可靠评估.

科学领域:

生物化学生物化学
药理学药理学是指药理学的学科.
细胞生物学细胞生物学

背景情况:

甲状腺刺激激素 (TSH) 对于甲状腺功能至关重要.
现有的测定可能无法完全捕捉体内生物制药动力学机制.
需要强大的体外方法来评估TSH的生物活性.

研究的目的:

开发和验证基于细胞的TSH生物活性体外测试.
在体内模拟TSH作用的药理动力学机制.
支持TSH药物开发,表征和质量控制.

主要方法:

构建了两个HEK293-TSHR细胞系,针对Gαs-cAMP-PKA和Gαq/11-PLC-Ca2+通路.
建立并验证了两种使用 luciferase 记者进行的记者基因测定 (RGA).
优化了实验参数,并根据ICH,中国药典和USP指南进行了验证.

主要成果:

在两个细胞系中,TSH显示出良好的剂量反应关系,符合四参数模型.
开发的RGA显示出良好的特异性,准确性,精度和线性.
经过验证的测定有效地通过关键的体内途径测量TSH介导的信号传递.

结论:

开发的基于细胞的测试准确模拟了TSH的体内信号通路.
这些经过验证的RGA适用于评估TSH药物生物活性,产品特征,释放和稳定性.
这些分析支持生物类似性可比性研究,并加强TSH治疗产品质量评估.

关键词:

生物活性生物活性方法验证方法的验证方法.质量控制质量控制质量控制报告员基因检测试验甲状腺刺激激素激素激发甲状腺刺激激素.

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