产业的观点是关于对亲肠道组合产品的容器封闭完整性的整体方法
Klaus Wuchner1, Helen C Brown2, Fabiana Canal3
1Janssen R&D, BTDS Analytical Development, Hochstrasse 201, 8200 Schaffhausen, Switzerland.
概括
确保亲肠道生物制剂的容器封闭完整性 (CCI) 是至关重要的. 通过设计质量 (QbD) 将CCI纳入流程,减少了对最终产品进行广泛测试的需求.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 医疗设备工程 医疗设备工程
背景情况:
- 亲肠道生物药物越来越多地被开发为与药物输送装置的组合产品.
- 对于这些医疗器械来说,在整个产品生命周期中保持无菌性至关重要.
研究的目的:
- 总结一个整体的行业方法,以确保组合产品的容器封闭完整性 (CCI).
- 为将CCI质量纳入整体制造过程提供基于科学的理由.
主要方法:
- 描述目前用于CCI表征的分析技术.
- 在组合产品开发过程中概述良好制造实践 (GMP) CCI测试.
主要成果:
- 容器封闭完整性 (CCI) 是一个关键的质量属性 (CQA),需要在整个产品生命周期内考虑.
- 将CCI集成到设计和装配过程中,比单独进行最终测试更好.
结论:
- 设计质量 (QbD) 原则可以显著减少或消除对组合产品的常规批量或稳定性测试的需求.
- 对CCI的积极主动,内置的方法确保了产品质量和患者安全.
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