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对高阶结构,超分子高阶结构和聚合物在寡核酸治疗中的评估和表征的策略

Laure-Elie Carloni¹, George Bou-Assaf², Arani Chanda³

¹Therapeutics Development & Supply, Johnson & Johnson, Beerse, Belgium.

Journal of pharmaceutical sciences

|June 24, 2025

概括

合成的寡核酸可以形成高阶结构 (HOS) 和聚合物,影响制造业. 本文提出了在药物开发过程中对这些物种进行表征的系统策略,以确保产品质量.

科学领域:

制药科学制药科学
生物技术是生物技术.
药物开发药物开发

背景情况:

合成寡核酸是一种有前途的治疗类别,针对各种疾病.
由于其主要结构,寡核酸治疗药物可以形成更高阶结构 (HOS) 和聚合物.
这些意想不到的结构可能会影响药物 (DS) 和药物制品 (DP) 制造.

研究的目的:

为提供对HOS和聚合行为在寡核酸治疗的概述.
为这些物种的评估和表征提出系统的策略.
为预测和减轻意外的HOS和聚合物形成提供指导.

主要方法:

文献审查和综合行业经验.
开发拟议的特征化策略.
专注于在产品开发过程中在相关条件下进行评估.

主要成果:

氧核酸HOS和聚合受到溶解介质和度等因素的影响.
目前关于这些物种特征的指导是有限的.
拟议的战略提供了科学和系统的评估方法.

结论:

对HOS和聚合物的系统性表征对于寡核酸治疗开发至关重要.
实施设计的工作流可以帮助减轻意外物种的形成.
在开发过程中的积极评估确保了产品质量和制造的一致性.

关键词:

聚合物聚合物聚合物这是一种反意义的寡核酸.亚普特美尔 (Aptamer) 是一种药物.形状的形成形状的形成高阶结构的结构是高阶的.有氧核酸的部分.自动组装自动组装小的干扰RNA可以干扰RNA.这是一个超分子的超分子.

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