Collaborative Research: Quality Profile Modeling and Control with Applications in Tissue-engineered Scaffolds Fabrication

这项合作研究的目标是通过整合先进的统计技术和制造过程的专业知识，为质量概况的建模和控制开发一种通用和系统的方法。在工业实践中，有一种日益普遍的情况，即过程或产品的质量是由响应变量和解释变量之间的关系（称为概要）来表征的。本研究将建立适当的统计模型来表征工艺参数对所得质量曲线的影响，并基于工艺曲线模型进行过程控制，包括空间均匀性控制和变化检测。在构建模型时将使用分层建模方法，并将开发先进的贝叶斯方法用于模型估计和变化检测。该过程的专家知识将被纳入方法论开发。所提出的方法将在组织工程支架制造过程中使用降解概况进行验证。这项研究的结果将通过为质量概况提供科学基础和一套连贯的质量工程工具来填补先进制造业的空白。这项工作的一个独特贡献是表征了工艺参数对质量概况的影响，这将为基于质量概况的工艺设计、监控和优化奠定基础。此外，将研究结果应用于组织工程支架制造中降解特征的控制，将使生产满足人类不同需求的组织工程支架产品成为可能，从而克服开发工程组织/器官（如骨、肝、血管和心脏瓣膜）的关键障碍，以满足我国对组织移植的巨大需求。

The objective of this collaborative research is to develop a generic and systematic methodology for the modeling and control of quality profiles through the integration of advanced statistical techniques and expert knowledge of manufacturing processes. There is an increasingly common situation in industry practices where the quality of a process or product is characterized by a relationship between a response variable and an explanatory variable, called profiles. This research will build appropriate statistical models to characterize the effect of process parameters on the resulting quality profiles, and conduct process control, including spatial uniformity control and change detection, based on the process-profile models. A hierarchical modeling approach will be used in building the models, and advanced Bayesian approaches will be developed for model estimation and change detection. Expert knowledge of the process will be incorporated in the methodology development. The proposed approaches will be validated using degradation profiles in tissue-engineered scaffold fabrication processes.The results of this research will fill the gap in the state-of-art manufacturing by providing a scientific base and a coherent set of quality engineering tools for quality profiles. A unique contribution of this work is the characterization of the effect of process parameters on quality profiles, which will establish a foundation for process design, monitoring and optimization based on quality profiles. Moreover, the application of the results in the control of degradation profiles in tissue-engineered scaffold fabrication will make it possible to produce tissue-engineered scaffold products that satisfy different requirements for human uses, and thus overcome critical barriers in developing engineered tissues/organs such as bone, liver, blood vessel, and heart valve to meet the vast need for tissue grafts in our nation.