The bioprocessing industry is undergoing a significant transformation in its approach to quality assurance, shifting from the traditional Quality by Testing (QbT) to Quality by Design (QbD). QbD, a systematic approach to quality in process development, integrates quality into process design and control, guided by regulatory frameworks. This paradigm shift enables increased operational efficiencies, reduced market time, and ensures product consistency. The implementation of QbD is framed around key elements such as defining the Quality Target Product Profile (QTPPs), identifying Critical Quality Attributes (CQAs), developing Design Spaces (DS), establishing Control Strategies (CS), and maintaining continual improvement. The present critical analysis delves into the intricacies of each element, emphasizing their role in ensuring consistent product quality and regulatory compliance.

中文翻译：

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基于模型的生物工艺开发路线图


生物加工行业的质量保证方法正在经历重大转变，从传统的质量源于测试 (QbT) 转向质量源于设计 (QbD)。 QbD 是一种流程开发质量的系统方法，在监管框架的指导下将质量整合到流程设计和控制中。这种范式转变可以提高运营效率、缩短上市时间并确保产品一致性。 QbD 的实施围绕关键要素构建，例如定义质量目标产品概况 (QTPP)、识别关键质量属性 (CQA)、开发设计空间 (DS)、建立控制策略 (CS) 和保持持续改进。当前的关键分析深入研究了每个要素的复杂性，强调了它们在确保一致的产品质量和法规遵从性方面的作用。