I/UCRC Phase II: Collaborative Research: Center for Pharmaceutical Development (CPD)

I/UCRC 第二阶段：合作研究：药物开发中心 (CPD)

• 批准号: 1540011
• 负责人: Eric Munson
• 金额: $ 22.5万
• 依托单位: University of Kentucky Research Foundation
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-10-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1540011&HistoricalAwards=false
• 关键词: UCRC; Phase; II; Collaborative; Research

Despite significant advances in the pharmaceutical industry over the last 50 to 100 years, there are still many problems with the drug supply, including drug shortages, drug manufacturing failures, drug recalls due to manufacturing issues, and problems with formulating and manufacturing new drugs that don?t dissolve or aren?t stable over time. The Center for Pharmaceutical Development focuses on increasing the safety and lowering the cost of drugs through research into the formulation and manufacturing of both innovator and generic drugs. The research interests of the center are threefold. First, the center is developing new biological catalysts that are used to synthesize drugs in a way that is more efficient and safer for the environment. Second, the center is improving analysis methods for determining what happens to the drug during the manufacturing process, and how that might lead to product failure. Finally, the center is focused on large-molecule drugs such as proteins and antibodies, which are emerging as potent new therapies. The societal benefit of this research would ultimately be cheaper and safer drugs for the patient.Despite huge progress in pharma over the last 50 to 100 years, there are still a lot of unmet needs which cause shortened lifespans and unnecessary suffering by patients. However, the development of novel drugs takes a lot of time (commonly more than 10 years) and money (commonly more than $1-2 billion). After discovery, the late-stage development begins, with clinical trials, manufacturing studies, especially process development and scale-up, and also with the development of the active ingredient into a drug product, such as a tablet, or an injectable. Development into a drug product requires solutions for formulation and drug delivery. The Center for Pharmaceutical Development (CPD) covers late-stage development in the development of new drugs; CPD focuses on manufacturing, formulation, and analytical tools. In the upcoming phase II (2015-2020), the CPD will operate at three sites: Georgia Tech (GT)/Emory in Atlanta, GA, the University of Kentucky (UK), in Lexington, KY, and now also at the University of Delaware in Newark, DE. Georgia Tech/Emory will focus on highly selective and environmentally benign biological catalysts and integration of reaction and separation (with Delaware); the University of Kentucky site will contribute with their unique strength in analyzing and stabilizing solid pharmaceuticals, both small molecules and therapeutic proteins (?biologics?) (with Delaware); and the University of Delaware will add strength in the separation and purification of therapeutic proteins (?biologics?) and in formulation, i.e. in keeping such biologic stable. The challenges above draw in a significant number of women and underrepresented minority students. Of the graduate students supported wholly or in part by the CPD, more than half (53%) were women and 18% were underrepresented minorities.

尽管在过去的50至100年中，制药行业取得了重大进展，但药物供应的问题仍然存在许多问题，包括药物短缺，药物制造失败，由于制造问题而引起的药物召回以及配制和制造新药的问题，这些药物不会随着时间的流逝而消失或稳定。药物开发中心的重点是通过研究和制造创新者和仿制药的制造和制造来提高安全性并降低药物的成本。 该中心的研究兴趣是三倍。 首先，该中心正在开发新的生物催化剂，这些催化剂用于以对环境更有效和更安全的方式合成药物。 其次，该中心正在改善分析方法，以确定制造过程中药物发生的情况，以及如何导致产品失效。 最后，该中心专注于大分子药物（例如蛋白质和抗体），这些药物正在成为有效的新疗法。 这项研究的社会益处最终将对患者更便宜，更安全。尽管在过去的50至100年中，制药公司取得了巨大进展，但仍有很多未满足的需求会导致患者的寿命缩短和不必要的痛苦。但是，新型药物的开发需要大量时间（通常超过10年）和金钱（通常超过10-2亿美元）。 发现后，通过临床试验，制造研究，尤其是过程开发和扩展，以及将活性成分的开发到药物（例如片剂或可注射剂）中的开发，尤其是过程开发和扩展。 开发到药物产品需要制定和药物输送的解决方案。 药物开发中心（CPD）涵盖了新药开发的晚期发展； CPD专注于制造，配方和分析工具。在即将到来的II阶段（2015-2020）中，CPD将在三个地点运营：佐治亚州亚特兰大的佐治亚理工学院（GT）/埃默里，位于佐治亚州亚特兰大，佐治亚州肯塔基大学（英国），肯塔基州列克星敦，现在在纽瓦克市特拉华大学，位于纽瓦克，德国。佐治亚理工学院/埃默里（Georgia Tech/Emory）将专注于高度选择性和环境良性生物学催化剂以及反应和分离的整合（与特拉华州）；肯塔基大学的地点将在分析和稳定固体药物（小分子和治疗蛋白（？生物学？）（与特拉华州）的分析和稳定固体药物方面，为其独特的力量做出了贡献；特拉华大学将在治疗蛋白的分离和纯化（？生物制剂？）和表述中增加力量，即保持这种生物稳定。上面的挑战涉及大量妇女和代表性不足的少数民族学生。在完全或部分支持CPD的研究生中，女性有超过一半（53％），而18％的妇女代表人数不足。