IUCRC Phase II+ Clemson University: Advanced Mammalian Biomanufacturing Innovation Center (AMBIC)

IUCRC 二期克莱姆森大学：先进哺乳动物生物制造创新中心 (AMBIC)

• 批准号: 2100442
• 负责人: Sarah Harcum
• 金额: $ 61.25万
• 依托单位: Clemson University
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2100442&HistoricalAwards=false
• 关键词: IUCRC; Phase; II+; Clemson; University

The Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) represents a unique opportunity to maintain national excellence and US technological leadership in the production of life-saving medicines. AMBIC is an NSF-supported Industry-University Cooperative Research Center (IUCRC) focused on using animal cells to produce biologic drugs. AMBIC serves as a catalyst for technology innovation by bringing together academic researchers from five universities (Johns Hopkins University (JHU), Clemson University (CU), University of Delaware (UD), University of Maryland College Park (UMD), and University of Massachusetts Lowell (UML). Industrial and federal mentors identify engineering challenges that limit the production of important medicines used to treat cancer and other diseases. Next, academic, federal, and industrial researchers work cooperatively to develop solutions to improve the quantity and quality of these drug products. These transformative advances may speed medicines to market and lower manufacturing costs, reducing health care costs for consumers by making biopharmaceuticals more affordable and available. The research conducted by AMBIC has been supported by the leading biopharma and supplier companies and federal institutes throughout Phase I and continuing into Phase II+. AMBIC contributes to the scientific community by educating students from diverse backgrounds for careers in biotechnology and biopharmaceutical industries. AMBIC's Phase II+ research goals focus on: 1) industrially-relevant biology, 2) process monitoring and control, and 3) consensus and standardization for advancing upstream biomanufacturing. Cell line stability robustness and productivity are investigated for Chinese hamster ovary (CHO) and other industrial mammalian hosts. Novel analytic tools, sensors, and instrumentation are developed and implemented with advanced system modeling and advanced media and culture operations are designed and deployed to generate optimized processes for developing proteins and other biologics. AMBIC’s industrial members include large integrated biopharma companies, manufacturers, suppliers, consultants, and federal institutes. Faculty researchers are drawn from five university sites using a centralized model including experts in CHO biology, metabolism, kinetics, and thermodynamics (JHU). CU brings expertise in advanced process control, bioreactor optimization, genomic and transcriptomic analysis, and protein glycosylation. UD offers expertise in systems and synthetic biology. UMD brings expertise in sensor and regulatory sciences. UML provides expertise in process development, analytics, and product characterization. By bringing together academic researchers and students from diverse backgrounds with industrial and federal partners, AMBIC is contributes to technology innovation in mammalian bioprocessing, ensuring the development and manufacture of the next generation of life-saving biologic medicines for patients. This award is co-funded by the following Programs: Industry University Cooperative Research Centers Program in the Division of Industrial Innovation and Partnerships - Engineering Directorate and the Systems and Synthetic Biology Program in the Division of Molecular and Cellular Biosciences (MCB) - Biological Sciences DirectorateThis 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.

先进哺乳动物生物制造创新中心 (AMBIC) 为保持国家卓越性和美国在救生药物生产方面的技术领先地位提供了独特的机会。AMBIC 是 NSF 支持的产学合作研究中心 (IUCRC)，专注于利用动物细胞。 AMBIC 汇集了来自五所大学（约翰·霍普金斯大学 (JHU)、克莱姆森大学 (CU)、特拉华大学 (UD)、大学）的学术研究人员，成为技术创新的催化剂。马里兰大学帕克分校 (UMD) 和马萨诸塞州洛厄尔大学 (UML) 工业和联邦导师发现了限制用于治疗癌症和其他疾病的重要药物生产的工程挑战。开发解决方案以提高这些药品的数量和质量。这些变革性的进步可能会加快药品上市速度并降低制造成本，从而使生物制药变得更便宜和更容易获得，从而降低消费者的医疗保健成本。领先的生物制药和供应商公司以及联邦机构在第一阶段和第二阶段+阶段通过教育来自不同背景的学生从事生物技术和生物制药行业，AMBIC 的第二阶段+研究目标侧重于：1）工业相关生物学。 ，2）过程监测和控制，以及3）针对中国仓鼠卵巢（CHO）推进上游生物制造的共识和标准化。新型分析工具、传感器和仪器通过先进的系统建模进行开发和实施，并设计和部署先进的培养基和培养操作，以生成用于开发蛋白质和其他生物制品的优化流程，包括大型综合生物制药。公司、制造商、供应商、顾问和联邦机构的研究人员来自五个大学，使用集中模型，其中包括 CHO 生物学、新陈代谢、动力学和热力学 (JHU) 方面的专家，带来了先进过程控制、生物反应器优化、基因组和转录组分析以及蛋白质糖基化提供系统和合成生物学方面的专业知识，UML 通过汇集学术研究人员和学生提供工艺开发、分析和产品表征方面的专业知识。 AMBIC 与工业和联邦合作伙伴有着不同的背景，正在为哺乳动物生物加工的技术创新做出贡献，确保为患者开发和生产下一代救生生物药物。该奖项由以下机构共同资助。项目：工业创新与合作司 - 工程理事会下的工业大学合作研究中心项目以及分子和细胞生物科学 (MCB) - 生物科学理事会下的系统和合成生物学项目该奖项反映了 NSF 的法定使命，并被视为值得通过使用基金会的智力优点和更广泛的影响审查标准进行评估来支持。