Quality by Design risk assessments supporting approved antibody products.
Quality by Design risk assessments supporting approved antibody products.
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DOI：
10.1080/19420862.2016.1232218
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发表时间：
2016
期刊：
影响因子：
5.3
通讯作者：
Kelley B
中科院分区：
文献类型：
--
作者：
Kelley B
质量源于设计（QbD）是一项全球监管计划，旨在通过设计生产工艺和控制措施来加强药物开发，以始终如一地提供按预期运行的产品。人用药品注册技术要求国际协调会议（ICH）指南文件ICHQ 8 -11中描述了与QbD相关的药物开发原则。1-4 2008年，美国食品药品监督管理局（FDA）启动了生物制品QbD试点计划，公司可以通过完整的生物许可申请或补充申请做出贡献。许多生物制药公司参与了试点计划，并在建立批准前和批准后备案的基础方面取得了进展。5试点的一个成果是，2010年批准了罗氏/基因泰克生产单克隆抗体的原料药工艺多产品/多地点转移的扩大变更方案。6 A-mAb案例研究为该领域作出了另一项重大贡献。7它描述了7家公司（Pfizer、GlaxoS-mithKline、Genentech、Abbott、Amgen、Lilly、MedImmune）使用的QbD主要成分的各种方法，这些公司在生物制剂的开发和商业化方面具有经验。这份出版物提出了一套不同的解决方案，以共同的问题，但由于许多公司参与，它缺乏一个自我一致的形式主义。近年来，在改进QbD原理的应用方面继续取得进展，尽管进展比预期的要慢。8-11罗氏/Genentech已在美国使用QbD原则许可了2种治疗性重组单克隆抗体产品obinutuzumab（Gazyva®）和atezolizumab（Atzentriq ®）。12-13我们相信这些代表了第一批全面基于QbD信息的生物制剂批准，包括许可申请中包含的批准的设计空间声明以及批准后的生命周期管理计划。罗氏/基因泰克最近发表了7篇文章，描述了QbD原则在治疗性单克隆抗体开发和许可中的应用。14-20这些文章提出了一套自洽的风险评估和逻辑元素，这些评估和逻辑元素是在过去十年中开发的，基于FDA和欧洲药品管理局试点QbD计划的改进以及
Quality by Design (QbD) is a global regulatory initiative that enhances pharmaceutical development through the design of the manufacturing process and controls to consistently deliver a product that performs as intended. The principles of pharmaceutical development relevant to QbD are described in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance documents ICHQ8-11. 1-4 In 2008, the Food and Drug Administration (FDA) initiated a QbD pilot program for biological products wherein companies could contribute either with full biological license applications or supplements. Many biopharmaceutical firms participated in the pilot program, and progress was made on establishing the basis for pre-and post-approval filings. 5 One outcome of the pilot was an approval, granted in 2010, for an expanded change protocol for multiproduct/multisite transfer of drug substance processes for production of monoclonal antibodies at Roche/Genentech. 6 The A-mAb case study provided another substantial contribution to the field. 7 It described a variety of approaches to the major elements of QbD used by 7 companies (Pfizer, GlaxoS-mithKline, Genentech, Abbott, Amgen, Lilly, MedImmune) with experience in the development and commercialization of biologics. This publication presented a diverse set of solutions to common problems, but, because many companies were involved, it lacked a self-consistent formalism. Advances in refining the applications of QbD principles have continued in recent years, although progress is slower than hoped. 8-11 Roche/Genentech has licensed 2 therapeutic recombinant monoclonal antibody products, obinutuzumab (Gazyva®) and atezolizumab (Tencentriq®), in the US using QbD principals. 12-13 We believe these represent the first approvals for biologics that were comprehensively based on QbD information, including approved design space claims as well as a post-approval lifecycle management plans, contained in the license application.Roche/Genentech recently published 7 articles describing the application of the principles of QbD for development and licensure of therapeutic monoclonal antibodies. 14-20 These articles present a self-consistent set of risk assessments and logical elements developed over the last decade, based on refinement through the FDA and European Medicines Agency pilot QbD programs and approvals of
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影响因子：
1.7
作者：
Ohage, Ettore;Iverson, Raquel;Vega, Maria
通讯作者：
Vega, Maria
影响因子：
5.3
作者：
Luciani, Francesca;Galluzzo, Sara;Melchiorri, Daniela
通讯作者：
Melchiorri, Daniela
影响因子：
1.7
作者：
Hakemeyer, Christian;McKnight, Nathan;Wurth, Christine
通讯作者：
Wurth, Christine
DOI：
10.1007/978-1-4939-2316-8_2
发表时间：
2015-01-01
期刊：
QUALITY BY DESIGN FOR BIOPHARMACEUTICAL DRUG PRODUCT DEVELOPMENT
影响因子：
--
作者：
Rellahan, Barbara L.;Kozlowski, Steven;Swann, Patrick
通讯作者：
Swann, Patrick
影响因子：
1.7
作者：
Kepert, J. Felix;Cromwell, Mary;Taticek, Ron
通讯作者：
Taticek, Ron