Planning IUCRC at University of Minnesota-Twin Cities: Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP)

国际自然与自然保护委员会的规划项目重点是建立一个三所大学合作的中心，以推进基础材料科学和工程研究，促进高质量药物产品的开发。制药行业在美国是一个重要的，万亿美元的产业，对美国人口的健康和福祉有着广泛的影响。然而，也存在一些主要问题，如市场增长放缓、新药上市时间长、成本高、产品质量和药品短缺等。这主要是由于含有许多不同成分的药品的高度复杂性，对制造工艺的了解不足，以及缺乏从材料特性评估产品性能的预测工具。本中心旨在解决这些问题和行业的需求，通过范式转换机制的方法，以发展对工艺和材料性能对产品性能影响的预测性理解。拟议的基于材料科学的转化研究有望产生重大的经济影响，因为它提高了产品质量，减少了产品故障，简化了制造操作，并显著减少了产品开发时间和制造成本。该中心还将通过尖端研究方法、技术转让、创新和创业方面的培训，对代表性不足的少数群体的学生产生积极影响。提出的研究旨在发展对颗粒基药物产品的结构-功能-性能及其工艺工程的基本理解，为应用晶体和颗粒工程来提高药物的生物利用度、可制造性、产品稳定性和产品质量铺平道路。中心的研究重点是：A)颗粒和晶体工程，B)材料和产品性能的模型预测理解，以及C)生物利用度增强和稳定性。CIMSEPP团队将推进和促进对受制造工艺影响的分子和颗粒水平上药物和添加剂之间的材料特性和相互作用的基本理解。UMN团队在粉末表征和性能增强方面的专业知识，通过集成晶体工程和颗粒设计，将能够开发出高效且易于采用的策略来解决制造问题。通过系统地表征材料的长度尺度，从分子维度到单晶/颗粒，到粉末，再到成品，将获得对结构-性能关系的基本理解。CIMSEPP内部的高度协作有望通过使用更高效的设计和开发流程、强大的规模扩展和连续生产来实现高质量的药品，从而使美国人口的健康和福祉受益。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This IUCRC planning project focuses on establishing a collaborative three-university center to advance fundamental materials science and engineering research for facilitating high quality drug product development. The pharmaceutical sector in the USA is a major, trillion-dollar industry, having broad impacts on the health and well-being of the US population. Yet, there are major problems, e.g., slowing market growth, long time and high costs of bringing a new drug to market, product quality, and drug shortages. These arise largely due to highly complex nature of pharmaceutical products that contain many different components, the inadequate understanding of the manufacturing processes, and lack of predictive tools to assess product performance from material properties. This Center aims to address these problems and the needs of industry through paradigm shifting mechanistic approach for developing predictive understanding of the impact of processes and material properties on product performance. Proposed material science based translational research is expected to have significant economic impact, due to improved product quality, reduced product failures, simplified manufacturing operations, and significantly reducing product development times and manufacturing costs. The Center will also positively impact students from under-represented minority groups, through training in cutting edge research methodologies, tech-transfer, innovation and entrepreneurship. The proposed research aims at developing a fundamental understanding of structure-function-performance of particulate-based drug products and their process engineering, paving the way for applying crystal and particle engineering towards enhancing drug bioavailability, manufacturability, product stability, and product quality. Center research thrusts, designed for transformative impact, are: A) Particle and Crystal Engineering, B) Model Predictive Understanding of Materials and Product Performance, and C) Bioavailability Enhancement and Stability. The CIMSEPP team will advance and promote fundamental understanding of the material properties and interactions among drug(s) and additives at the molecular and particulate level as affected by manufacturing processes. The UMN team's expertise in powder characterization and property enhancement through integrated crystal engineering and particle design will enable the development of both highly effective and easy-to-adopt strategies to solve manufacturing problems. Fundamental understanding in structure - property relationship will be gained through systematically characterizing materials at length scales, ranging from molecular dimension to single crystal/particles, to powders, and to finished products. The highly collaborative efforts within the CIMSEPP are expected to benefit the health and well-being of the U.S. population through enabling high quality pharmaceutical products using more efficient design and development process, robust scale-up, and continuous manufacturing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.