通过设计质量分析提供的增强开发工具来支持质量控制方法的切换
Philippe Simeoni1, Michael Deissler2, Roland Bienert1
1Technical R&D Biologics, Novartis Pharma AG, Basel, Switzerland.
Biotechnology and bioengineering
|August 1, 2023
概括
通过设计的分析质量 (AQbD) 成功开发了一种毛细管电泳方法,以取代SDS-PAGE用于单克隆抗体测试. 这种方法确保了方法的稳定性,并保持了对药品质量控制至关重要的数据相关性.
科学领域:
- 药品分析 药品分析
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 设计质量 (QbD) 原则在制药开发中至关重要.
- 传统的SDS-聚烯胺凝电泳 (SDS-PAGE) 对单克隆抗体分析有局限性.
- 分析QbD (AQbD) 为方法开发提供了一种系统的方法.
研究的目的:
- 在减少条件下 (rCE-SDS) 开发毛细管电泳二甲硫酸盐方法.
- 取代现有的SDS-聚烯胺凝电泳 (SDS-PAGE) 方法,用于产品释放和稳定性测试.
- 确保新方法是稳健的,并保持数据完整性.
主要方法:
- 定义的分析目标配置文件 (ATP) 和性能要求.
- 对方法参数进行了系统的风险评估.
- 使用实验设计 (DoE) 来建立一种方法可操作设计区域 (MODR).
- 进行了一项桥梁研究,将rCE-SDS与SDS-PAGE进行比较.
主要成果:
- AQbD方法确定了关键方法参数,并建立了一个MODR.
- 与SDS-PAGE相比,rCE-SDS方法显示了更高的灵敏度.
- 建立了转换因子,以关联历史和新方法数据.
- 方法的稳定性得到了显著的改善.
结论:
- 系统的AQbD应用阐明了分析方法的复杂输入-输出关系.
- 将方法性能与产品质量属性的联系是降低分析方法过渡风险的关键.
- 开发的rCE-SDS方法适合在单克隆抗体控制策略中取代SDS-PAGE.
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