Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program
Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program
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DOI：
10.1007/978-1-4939-2316-8_2
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发表时间：
2015-01-01
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影响因子：
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通讯作者：
Swann, Patrick
中科院分区：
文献类型：
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作者：
Rellahan, Barbara L.;Kozlowski, Steven;Swann, Patrick
2008年7月2日，美国食品药品监督管理局（FDA）药物评价和研究中心生物技术产品办公室（OBP）发布了一份联邦注册通知，说明其设计质量（QbD）试点计划。该计划旨在定义OBP监管的蛋白质产品的临床相关属性，并将其与生产工艺联系起来。该计划考虑了QbD方法，以补充单元操作以及原始生物许可证申请（BLA）。试点计划接受了六份原始BLA申请和四份批准后补充申请。本章总结了与QbD概念在生物技术产品开发和生产中的应用相关的单克隆抗体产品的试点项目提交和会议中的关键观察结果。
On July 2, 2008, the Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, Food and Drug Administration (FDA) published a Federal Register notice for their Quality by Design (QbD) pilot program. The program was designed to define clinically relevant attributes for protein products regulated by OBP and link them to manufacturing processes. The program considered QbD approaches to unit operations in supplements as well as original biologic license applications (BLA). The pilot program accepted six original BLA applications and four postapproval supplements. This chapter summarizes key observations from the pilot program submissions and meetings for monoclonal antibody products related to the application of QbD concepts to biotechnology product development and manufacture.