Implementing quality by design for biotech products: Are regulators on track?
Implementing quality by design for biotech products: Are regulators on track?
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DOI：
10.1080/19420862.2015.1023058
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发表时间：
2015-05-04
期刊：
影响因子：
5.3
通讯作者：
Melchiorri, Daniela
中科院分区：
文献类型：
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作者：
Luciani, Francesca;Galluzzo, Sara;Melchiorri, Daniela
质量源于设计（QbD）是一种创新的药物开发方法，已开始实施到监管框架中，但目前主要针对化学药物。最近，第一个使用广泛的 QbD 概念开发的单克隆抗体在欧盟获得了上市许可，为未来进一步监管部门批准采用这一尖端技术概念的复杂产品铺平了道路。在本文中，我们报告并评论了欧洲药品管理局生物制品工作组和人用药品委员会在评估过程中与生物技术衍生药品实施广泛的 QbD 方法相关的关键问题的非公开讨论中获得的见解和经验教训。分享这些见解可能对一般生物技术产品（特别是单克隆抗体）的 QbD 未来发展有用。
Quality by design (QbD) is an innovative approach to drug development that has started to be implemented into the regulatory framework, but currently mainly for chemical drugs. The recent marketing authorization of the first monoclonal antibody developed using extensive QbD concepts in the European Union paves the way for future further regulatory approvals of complex products employing this cutting-edge technological concept. In this paper, we report and comment on insights and lessons learnt from the non-public discussions in the European Medicines Agency's Biologicals Working Party and Committee for Medicinal Products for Human Use on the key issues during evaluation related to the implementation of an extensive QbD approach for biotechnology-derived medicinal products. Sharing these insights could prove useful for future developments in QbD for biotech products in general and monoclonal antibodies in particular.