IUCRC Phase I NJIT: Center for Integrated Material Science and Engineering of Pharmaceutical Products (CIMSEPP)

美国的制药行业是一个价值万亿美元的主要行业，通过造福美国民众的健康和福祉，对他们产生了广泛的影响。尽管美国处于领导地位，但该行业仍面临重大问题，包括开发新分子的困难、将新药推向市场的成本高和时间长、缺乏足够和有效的监管科学、消费者药品的可负担性、质量问题和药品短缺。新冠肺炎疫情进一步加剧了其中许多挑战。这些问题表明，迫切需要创新研究和技术进步，以开发高质量的药品产品，实现生产效率，并支持美国的制药制造。IUCRC第一阶段项目通过建立一个由两所大学联合建立的制药产品集成材料科学与工程中心(CIMSEPP)来解决这些问题，NJIT作为牵头地点，明尼苏达州作为合作伙伴地点。CIMSEPP的使命是以更低的成本促进和促进对材料性质、分子和颗粒水平上的药物-添加剂相互作用以及制造工艺对产品质量和性能的基本了解。CIMSEPP团队将在三个行业审查的研究努力下发展对药物产品结构-功能-性能和过程工程的基本理解，这将：1)促进药物、其工程对应物和它们的混合物的关键性能的预测性增强，以提高产品质量；2)显著减少药物产品开发的时间和成本。主要进展包括：1)识别影响细颗粒行为的关键颗粒特性，2)更好地了解它们对粉末粘聚力和行为的影响，以及3)能够准确预测混合物和压片的性能。这种理解与粒子和晶体工程相结合，将使机械模型和预测工具的开发成为可能，使制造决策和更好的产品成为可能。恩智浦在粒子工程和接触物理方面的专业知识将使我们能够使用无因次参数(S)开发粒子团聚、药物含量均匀度和片剂重量变化的预测模型，该模型基于节省材料的粒子特性测量，如尺寸、形状和粗糙度。与数据驱动的方法相比，这种用于过程建模的模型和计算机模拟将使人们更好地了解传统和新兴技术，促进高质量产品和制造过程的高效设计，同时减少产品和可扩展过程开发的时间和成本。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The pharmaceutical sector in America is a major, trillion-dollar industry, having broad impacts on the US population through benefits to their health and well-being. Despite US leadership, the industry is facing major problems, including, difficulties in developing newer molecules, high cost and lengthy time of bringing a new drug to market, lack of adequate and efficient regulatory science, consumer drug affordability, quality issues, and drug shortages. The COVID-19 pandemic has further exacerbated many of these challenges. These issues point to an acute need for innovative research and technical advances to develop high-quality drug products, achieve manufacturing efficiency, and support US-based pharmaceutical manufacturing. This IUCRC phase I project addresses such issues through establishing a joint two-university Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP), with NJIT as a Lead Site and Minnesota as a Partner Site. Its mission is to advance and promote fundamental understanding of the material properties, drug-additive interactions at molecular and particulate level, as well as manufacturing processes, on product quality and performance, at lower cost.The CIMSEPP team will develop fundamental understanding of structure-function-performance of drug products and process engineering under three industry vetted Research Thrusts, which will, 1) promote predictive enhancement of key properties of drugs, their engineered counterparts, and their blends for improving product quality, and 2) significantly reduce time and cost of drug product development. Key advances include, 1) identification of critical particle properties that impact fine particle behavior, 2) better understanding of their impact on cohesion and behaviors of powders, and 3) enabling accurate prediction of properties of blends as well as compacted tablets. That understanding combined with particle and crystal engineering, will enable development of mechanistic models and predictive tools required for enabling manufacturing decisions and better products. NJIT’s expertise in particle engineering and contact-physics will enable development of predictive models for particle agglomeration, drug content uniformity, and tablet weight variation using dimensionless parameter(s) based on material sparing measurements of particle properties such as size, shape, and roughness. Compared to the data-driven approaches, such models and computer simulations for process modeling, will enable better understanding of traditional and emerging technologies, promoting efficient design of high-quality products and manufacturing processes, while reducing time and cost for product and scalable process development.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.