参考产品和生物类似产品的更高阶结构比较,在循环二元化谱上使用光谱距离计算
Hiroko Shibata1, Taiji Oyama2, Masato Kiyoshi1
1Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.
Journal of pharmaceutical sciences
|June 7, 2025
概括
本研究引入了一种量化方法,用于使用光谱距离来比较生物类似药和参考产品的质量属性. 这种方法可以对更高阶结构进行客观评估,证实了大多数已批准的生物类似药的相似性.
科学领域:
- 生物化学 生物化学
- 分析化学 分析化学
- 制药科学 制药科学
背景情况:
- 生物类似的开发需要严格的质量属性与参考产品的比较.
- 循环二重化 (CD) 光谱对于评估更高阶结构至关重要.
- 目前的CD光谱相似性评估通常是主观和视觉的.
研究的目的:
- 开发和应用客观的,定量方法来比较生物类似药和参考产品的CD光谱.
- 通过对光谱数据的统计分析来评估更高阶结构的相似性.
- 支持生物类似药物批准的监管决策.
主要方法:
- 将远紫外/CD光谱转换为单变数据 (光谱距离).
- 应用了质量范围方法和对量比较的同等性测试.
- 使用美国食品和药物管理局 (FDA) 推的统计方法.
主要成果:
- 可以证明CD光谱的客观和数值比较是可行的.
- 在大多数情况下,生物类似药和参考产品之间显示出很高的相似性.
- 在日本批准的生物类药物中,在光谱相似性方面发现了不到15%的异常.
结论:
- 将CD光谱转换为单变量数据可以客观地评估更高阶结构相似性.
- 应用的统计方法为生物相似性可比性研究提供了坚实的框架.
- 这种定量方法提高了对生物类似产品质量和监管接受度的信心.
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