I/UCRC Phase I (Site): Center for Pharmaceutical Development U. of Delaware Site

I/UCRC 第一阶段（现场）：特拉华大学药物开发中心现场

• 批准号: 1540003
• 负责人: Christopher Roberts
• 金额: $ 32.5万
• 依托单位: University of Delaware
• 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 2020-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1540003&HistoricalAwards=false
• 关键词: UCRC; Phase; Site; Center; Pharmaceutical

The biopharmaceutical industry represents one of the most technically demanding, high impact industries in the United States and worldwide, and is a driver of scientific innovation and economic prosperity. One of the fastest growing, and most promising type of new drug candidates, are those based on proteins as the active ingredient. However, there are a number of long-standing, industry-wide challenges that occur during the development and manufacturing of such ?pharmaceutical proteins?. The proposed I/UCRC Site at the University of Delaware (UD) will bring world-class expertise to the existing Center for Pharmaceutical Development (CPD), in technical areas that are central to innovation for the development of pharmaceutical proteins (so-called biopharmaceuticals). Examples include: more efficient purification processes, better product stability and reduced risk of side effects or unwanted immunogenic responses in patients, and improved control of manufacturing processes. The proposed, expanded CPD will be the most far-reaching industry-university consortium to date that is focused on pharmaceutical product development, rather than the more traditional focus on ?upstream? research and drug-discovery activities. The project areas it will address have the potential to greatly improve the efficiency and economics of drug development science and engineering, as well as the fundamental understanding and education of engineers and scientists in the industry. This can benefit the U.S. broadly in terms of domestic job creation, as well as improved time to market, cost to patients, and reduced risk for investors, based on the development and testing of new therapeutic proteins (sole focus of the UD Site) and innovator pharmaceutical products more generally (focus of CPD overall). The major technical areas for the biopharmaceutical industry that are the focus on the UD site for the CPD include: (i) commercial and pilot-scale bioreactors to produce recombinant protein for use as a drug; (ii) extensive purification to produce essentially pure therapeutic protein in aqueous solution; (iii) formulation of the purified protein to assure multi-year stability, robust manufacturing, and effective delivery to patients; (iv) analytical technologies and instrumentation to support extremely tight specifications at each of stages (i) to (iii). The faculty in the proposed UD Site for the CPD are world-recognized leaders in areas (i) to (iv), and will provide new strengths to the current CPD that complement the existing expertise in solid-state pharmaceutical stability and delivery, and development of industrial enzymes and related biotechnology products.

生物制药行业是美国和全球技术要求最高、影响力最大的行业之一，是科学创新和经济繁荣的驱动力。 增长最快、最有前途的新型候选药物之一是以蛋白质为活性成分的药物。 然而，有一些长期存在的，行业范围内的挑战，发生在开发和制造这样的？药用蛋白质？ 拟议的I/UCRC研究中心位于特拉华州（UD），将为现有的药物开发中心（CPD）带来世界一流的专业知识，这些技术领域对药物蛋白质（所谓的生物制药）的开发至关重要。 示例包括：更有效的纯化方法、更好的产品稳定性和降低的副作用或患者中不需要的免疫原性应答的风险，以及改进的制造过程控制。 拟议的，扩大的持续专业发展将是迄今为止最深远的工业大学联盟，专注于药品开发，而不是更传统的重点？上游？研究和药物发现活动。 它将涉及的项目领域有可能大大提高药物开发科学和工程的效率和经济性，以及对该行业工程师和科学家的基本理解和教育。 这可以使美国在创造国内就业机会方面受益，以及改善上市时间，患者成本和降低投资者风险，基于新治疗蛋白质的开发和测试（UD网站的唯一重点）和更普遍的创新药物产品（CPD整体重点）。 生物制药行业的主要技术领域是CPD UD中心的重点，包括：（i）商业和中试规模的生物反应器，以生产用作药物的重组蛋白;（ii）广泛纯化，以生产水溶液中基本上纯的治疗蛋白;（iii）纯化蛋白的制剂，以确保多年稳定性，稳健的生产和有效地输送给患者;（iv）生物制药行业的主要技术领域包括：（i）商业和中试规模的生物反应器，以生产用作药物的重组蛋白;（ii）广泛纯化，以生产水溶液中基本上纯的治疗蛋白;（iii）纯化蛋白的制剂，以确保多年稳定性，稳健的生产和有效地输送给患者。（iv）分析技术和仪器，以支持第（i）至（iii）阶段中每一阶段的严格规格。建议中的持续专业发展研究中心的教职员在（i）至（iv）方面均为世界公认的领导者，并将为目前的持续专业发展提供新的优势，以补充现有的固态药物稳定性和交付方面的专业知识，以及工业酶和相关生物技术产品的开发。