多属性方法 (MAM) 用于评估阿达利穆马布生物类似药的分析可比性
Silvia Millán-Martín1, Craig Jakes1, Sara Carillo1
1National Institute for Bioprocessing Research & Training, Fosters Avenue, Mount Merrion, Blackrock, A94 X099 Dublin, Ireland.
Journal of pharmaceutical and biomedical analysis
|June 29, 2023
概括
多属性方法 (MAM) 证实了七种阿达利穆马布生物类似药的分析相似性. 这种基映射技术确保了质量,并支持了低成本生物药物的可获得性.
科学领域:
- 生物制药学分析分析
- 分析化学是一种分析化学.
- 质谱测量质量谱测量
背景情况:
- 阿达利穆马布 (Humira®) 是一种非常成功的全人类单克隆抗体 (mAb).
- 专利到期导致阿达利穆马布生物仿制药进入市场,增加了可访问性,并可能降低成本.
- 评估生物相似性对于监管批准和患者安全至关重要.
研究的目的:
- 使用多属性方法 (MAM) 评估七种阿达利穆马布生物类似药的分析相似性.
- 为了证明MAM对全面的生物治疗可比性评估的有用性.
主要方法:
- 使用了多属性方法 (MAM),一种基于液态染色学和质谱学 (LC-MS) 的映射技术.
- 标志着参考产品的翻译后修改和评估的批量变异性.
- 与参考产品相比,评估了预定义的质量属性,并检测了与参考产品相比生物类似药的新峰值或修改的峰值.
主要成果:
- 证实了七种阿达利穆马布生物类似药的分析相似性.
- 建立了基于批量变化的相似度范围的统计间隔.
- 证明了MAM在高可信度质量属性分析和检测关键质量属性的能力.
结论:
- 多属性方法 (MAM) 是生物治疗可比性研究的一个强大而简单的方法.
- MAM为分析表征和生物相似性评估提供了一个强大的框架.
- 这项研究强调了MAM在确保复杂的生物药物的质量和可比性方面的潜力,如阿达利姆巴.
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