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

合作研究：质量剖面建模和控制及其在组织工程支架制造中的应用

• 批准号: 1266116
• 负责人: Jian Yang
• 金额: $ 13.28万
• 依托单位: Pennsylvania State Univ University Park
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1266116&HistoricalAwards=false
• 关键词: Collaborative; Research; Quality; Profile; Modeling

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.

这项合作研究的目标是通过整合先进的统计技术和制造工艺的专业知识，开发一种通用且系统的方法来建模和控制质量概况。在行业实践中，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（称为配置文件）之间的关系来表征。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概况的影响，并基于工艺概况模型进行过程控制，包括空间均匀性控制和变化检测。将使用分层建模方法来构建模型，并将开发高级贝叶斯方法用于模型估计和变化检测。该过程的专业知识将纳入方法开发中。所提出的方法将使用组织工程支架制造过程中的降解曲线进行验证。这项研究的结果将通过提供科学基础和一套连贯的质量工程工具来填补最先进的制造领域的空白。这项工作的独特贡献是表征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，将这些结果应用于控制组织工程支架制造中的降解曲线将使得生产满足人类不同用途要求的组织工程支架产品成为可能，从而克服开发工程组织/器官的关键障碍，例如如骨骼、肝脏、血管和心脏瓣膜，以满足我国对组织移植的巨大需求。