Planning IUCRC at St. John's University: Center for Integrated Material Science and Engineering for Pharmaceutical Products (CIMSEPP)

美国的制药行业是一个价值上万亿美元的产业，对其人口的健康和福祉有着巨大的影响。然而，与近年来半导体、电子、汽车、食品、化工等许多行业在制造技术方面取得的巨大进步不同，制药行业远远落后。根据美国食品和药物管理局（fda）最近的公开评论和报告，即使在过去半个世纪里，制药产品的开发和生产方式也没有太多创新。因此，美国面临着开发新药的风险和成本非常高，药品价格高，许多质量和监管问题，以及更重要的是药品短缺。药品制造科学和技术缺乏进展主要是由于药品的高度复杂性，药品由许多不同的成分组成，对制造过程中不同步骤所需的材料特性的理解不足，以及缺乏基于材料特性评估产品性能的预测工具。这个由三所大学组成的中心将汇集一个由工程和制药专家组成的团队，通过与制药行业的专家合作进行基础研究来解决这些问题。在美国使用的80%以上的药物是固体剂型，如由颗粒和颗粒组成的片剂和胶囊。甚至许多注射或吸入的产品也以微粒的形式产生。目前，人们对颗粒系统的行为知之甚少，导致了主要的开发和制造问题，需要替代方法来表征它们并预测它们的性能。此外，在药物发现过程中合成的超过三分之二的新化学实体是极不溶于水的，需要更新的技术来提高这些材料的溶解度、溶出率和生物利用度。还需要创新技术来满足个性化药物、靶向给药和防止滥用药物（阿片类药物）的迫切需求。如果没有材料科学的进步，在制药行业实施连续制造，这在其他行业是正常的，也是不可能的。圣约翰大学团队将运用其在药物产品开发、新型药物输送系统和药物加工方面的广泛专业知识，为解决这些问题做出贡献。该大学的工业制药创新实验室将利用其现代化的最先进设备进行晶体和颗粒工程、熔融挤出和造粒、纳米技术、喷雾干燥、3D打印和连续制造等方面的研究。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。

The pharmaceutical sector in the USA, a trillion-dollar industry, has tremendous impacts on the health and well-being of its population. However, unlike the enormous progress made in manufacturing technologies in recent years in many industries, including semiconductor, electronics, automotive, food, chemicals, etc., the pharmaceutical industry has lagged much behind. The situation is such that, according to recent public comments and reports by the US Food and Drug Administration, there has not been much innovations in how pharmaceutical products are developed and manufactured even during the past half a century. As a consequence, the US is facing very high risk and cost of developing new drug products, high drug prices, many quality and regulatory issues, and, importantly, drug shortages. The lack of progress in pharmaceutical manufacturing sciences and technologies could primarily be due to highly complex nature of pharmaceutical products that consist of numerous different components, the inadequate understanding of material properties necessary at different steps of the manufacturing process, and non-availability of predictive tools to assess product performance based on material properties. This three-university center will bring together a team of engineering and pharmaceutical experts to address these problems by conducting fundamental research in partnership with experts from pharmaceutical industry. Over 80 percent of medicines used in the USA are in solid dosage forms, such as tablets and capsules that consist of granules and particles. Even many products that are injected or inhaled are produced as particulates. Currently, there is poor understanding of the behavior of particulate systems resulting in major development and manufacturing issues, and alternative approaches are needed to characterize them and predict their performance. Additionally, over two-thirds of new chemical entities synthesized during drug discovery are extremely water-insoluble and newer technologies are needed to improve solubility, dissolution rate and bioavailability of such materials. Innovstive technologies are also needed to address the urgent needs of personalized medicines, targeted drug delivery, and abuse-deterrent medications (opioids). Implementation of continuous manufacturing in pharmaceutical industry, which is currently normal in other industries, is also not possible without advancement in materials sciences. The St. John's University team will contribute to resolving these issues by applying its extensive expertise in drug product development, novel drug delivery systems, and pharmaceutical processing. The university's modern state-of-the-art facilities in its Industrial Pharmacy Innovation Laboratory to conduct research on crystal and particulate engineering, melt extrusion and granulation, nanotechnology, spray drying, 3D printing and continuous manufacturing will be utilized.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.