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Updated: May 2, 2026

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创新方法支持治疗性蛋白质在水力动力学尺寸上的相似性,使用高通量动态光散射和强制降解

Ashwinkumar Bhirde1, Siri Harish2, Nicholas Trunfio2

  • 1Division of Product Quality Research VI, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. ashwinkumar.bhirde@fda.hhs.gov.

Scientific reports
|November 22, 2025
PubMed
概括

高吞吐量动态光散射 (HT-DLS) 提供了一种新的方法,通过评估水力动态尺寸来证明生物相似性. 这种方法,利用强制降解甜点,超出了简单的签名峰值,以获得强大的分析相似性.

关键词:
生物类药物是生物类药物.累积物 累积物 累积物 累积物动态光散射是一种动态光散射.水力动力学尺寸尺寸 水力动力学尺寸胰岛素是一种胰岛素.单克隆抗体是一种单克隆抗体.主要组件分析的主要组件分析.蛋白质聚合蛋白质的聚合.规范化 规范化 规范化

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