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

这项合作研究的目的是开发一个通用的和系统的方法，通过先进的统计技术和制造工艺的专业知识的集成建模和质量配置文件的控制。在工业实践中，越来越常见的情况是，过程或产品的质量由响应变量和解释变量之间的关系（称为配置文件）来表征。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工艺控制，包括空间均匀性控制和变化检测。在建立模型时将使用分层建模方法，并将为模型估计和变化检测开发先进的贝叶斯方法。在方法的制定过程中将纳入关于这一进程的专家知识。本研究的结果将为组织工程支架制造过程中的降解曲线提供科学依据和一套连贯的质量工程工具，从而填补最新制造技术中的差距。这项工作的一个独特的贡献是表征工艺参数对质量曲线的影响，这将为基于质量曲线的工艺设计、监测和优化奠定基础。此外，在组织工程支架制造的降解曲线的控制中的结果的应用将使得有可能产生满足人类使用的不同要求的组织工程支架产品，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物的巨大需求。

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.