通过设计质量使 RNA 平台生产工艺成为可能。
Quality by Design for enabling RNA platform production processes.
机构信息
Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK.
Centre for Process Systems Engineering, Department of Chemical Engineering, Faculty of Engineering, Imperial College London, London, UK; Department of Chemical and Biological Engineering, The University of Sheffield, Sheffield, UK.
出版信息
Trends Biotechnol. 2022 Oct;40(10):1213-1228. doi: 10.1016/j.tibtech.2022.03.012. Epub 2022 Apr 29.
RNA-based products have emerged as one of the most promising and strategic technologies for global vaccination, infectious disease control, and future therapy development. The assessment of critical quality attributes (CQAs), product-process interactions, relevant process analytical technologies, and process modeling capabilities can feed into a robust Quality by Design (QbD) framework for future development, design, and control of manufacturing processes. QbD implementation will help the RNA technology reach its full potential and will be central to the development, pre-qualification, and regulatory approval of rapid response, disease-agnostic RNA platform production processes.
基于 RNA 的产品已成为全球疫苗接种、传染病控制和未来治疗开发最有前途和最具战略意义的技术之一。关键质量属性 (CQA)、产品工艺相互作用、相关过程分析技术和过程建模能力的评估，可以为未来的开发、设计和制造过程控制提供稳健的质量源于设计 (QbD) 框架。QbD 的实施将帮助 RNA 技术充分发挥其潜力，并将成为快速反应、无病种 RNA 平台生产过程的开发、预认证和监管批准的核心。
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