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

生物制药行业是美国和世界范围内技术要求最高、影响最大的行业之一，是科学创新和经济繁荣的驱动力。以蛋白质为活性成分的新药是发展最快、最有前途的一类候选新药。然而，在此类产品的开发和制造过程中，存在一些长期存在的、全行业范围的挑战。制药蛋白质?。特拉华大学（University of Delaware）拟议的I/UCRC站点将为现有的药物开发中心（CPD）带来世界级的专业知识，这些技术领域对药用蛋白质（所谓的生物制药）的开发创新至关重要。例子包括：更有效的净化过程，更好的产品稳定性和降低副作用或患者不必要的免疫原性反应的风险，以及改进的生产过程控制。拟议中的扩大CPD将成为迄今为止影响最深远的产学研联盟，专注于制药产品开发，而不是更传统地专注于“上游”。研究和药物发现活动。它将解决的项目领域有可能极大地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。基于开发和测试新的治疗性蛋白质（UD Site的唯一重点）和更广泛的创新药物产品（CPD的整体重点），这可以使美国在国内创造就业机会、缩短上市时间、降低患者成本和降低投资者风险方面广泛受益。生物制药工业的主要技术领域是该项目的重点，包括：(i)商业和试验规模的生物反应器，以生产用作药物的重组蛋白；（ii）广泛纯化，在水溶液中生产基本纯净的治疗蛋白；（iii）纯化蛋白的配方，以确保多年的稳定性、稳健的生产和有效的给药；（iv）分析技术和仪器，以支持(i)至（iii）每个阶段的严格规格。该项目的教师在(i)到（iv）领域是世界公认的领导者，将为当前的CPD提供新的优势，补充现有的固态药物稳定性和输送、工业酶和相关生物技术产品开发方面的专业知识。

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.