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: 1939164
• 负责人: Eric Munson
• 金额: $ 11.55万
• 依托单位: Purdue University
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2021-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1939164&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.

尽管制药行业在过去50到100年里取得了重大进步，但药品供应仍然存在许多问题，包括药品短缺、药品生产失败、因生产问题而导致的药品召回以及配制和生产不符合标准的新药的问题。随着时间的推移，它不会溶解或不稳定。药物开发中心致力于通过研究创新药物和仿制药的配方和制造来提高药物的安全性并降低药物成本。 该中心的研究兴趣有三个。 首先，该中心正在开发新的生物催化剂，用于以对环境更有效、更安全的方式合成药物。 其次，该中心正在改进分析方法，以确定药物在制造过程中发生了什么，以及这如何可能导致产品失败。 最后，该中心专注于蛋白质和抗体等大分子药物，这些药物正在成为有效的新疗法。 这项研究的社会效益最终将是为患者提供更便宜、更安全的药物。尽管过去 50 到 100 年制药业取得了巨大进步，但仍然存在许多未满足的需求，导致患者寿命缩短和不必要的痛苦。然而，新药的开发需要大量的时间（通常超过10年）和金钱（通常超过1-20亿美元）。 发现后，后期开发开始，包括临床试验、制造研究，特别是工艺开发和放大，以及将活性成分开发成药物产品，例如片剂或注射剂。 药品的开发需要配方和药物输送的解决方案。 药物开发中心（CPD）涵盖新药开发的后期开发； CPD 专注于制造、配方和分析工具。在即将到来的第二阶段（2015-2020）中，CPD 将在三个地点运营：位于佐治亚州亚特兰大的佐治亚理工学院 (GT)/埃默里大学、位于肯塔基州列克星敦的肯塔基大学（英国）以及现在的大学位于特拉华州纽瓦克的特拉华州。佐治亚理工学院/埃默里大学将专注于高选择性和环境友好的生物催化剂以及反应与分离的集成（与特拉华州）；肯塔基大学网站将以其在分析和稳定固体药物（小分子和治疗性蛋白质（？生物制品？））方面的独特优势做出贡献（与特拉华州合作）；特拉华大学将在治疗性蛋白质（“生物制剂”）的分离和纯化以及制剂方面加大力度，即保持此类生物制剂的稳定性。上述挑战吸引了大量女性和代表性不足的少数族裔学生。在全部或部分由 CPD 支持的研究生中，超过一半 (53%) 是女性，18% 是代表性不足的少数族裔。