IUCRC Phase II+ University of Maryland: Center for Advanced Mammalian Biomanufacturing Innovation (AMBIC)

IUCRC 第二阶段 马里兰大学：先进哺乳动物生物制造创新中心 (AMBIC)

• 批准号: 2100632
• 负责人: William Bentley
• 金额: $ 61.25万
• 依托单位: University of Maryland, College Park
• 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=2100632&HistoricalAwards=false
• 关键词: IUCRC; Phase; II+; University; Maryland

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 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）代表了一个独特的机会，以保持国家卓越和美国在生产救生药物方面的技术领先地位。AMBIC是NSF支持的工业大学合作研究中心（IUCRC），专注于使用动物细胞生产生物药物。AMBIC汇集了来自五所大学的学术研究人员（约翰霍普金斯大学（JHU）、克莱姆森大学（CU）、特拉华州大学（UD）、马里兰州学院公园大学（UMD）和马萨诸塞州洛厄尔大学（UML）），成为技术创新的催化剂。工业和联邦导师确定工程挑战，限制用于治疗癌症和其他疾病的重要药物的生产。接下来，学术界、联邦和工业界的研究人员合作开发解决方案，以提高这些药品的数量和质量。这些变革性的进展可能会加快药物上市速度，降低制造成本，通过使生物制药更便宜和更容易获得，从而降低消费者的医疗保健成本。AMBIC进行的研究在整个I期和II+期得到了领先的生物制药和供应商公司以及联邦机构的支持。AMBIC通过教育来自不同背景的学生在生物技术和生物制药行业的职业生涯为科学界做出贡献。AMBIC的第二阶段+研究目标集中在：1）工业相关生物学，2）过程监测和控制，以及3）推进上游生物制造的共识和标准化。研究了中国仓鼠卵巢（CHO）和其他工业哺乳动物宿主的细胞系稳定性耐用性和生产率。新型分析工具，传感器和仪器的开发和实施与先进的系统建模和先进的媒体和培养操作的设计和部署，以产生优化的过程，开发蛋白质和其他生物制品。AMBIC的工业成员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。教师研究人员来自五所大学，使用集中模型，包括CHO生物学，代谢，动力学和热力学（JHU）的专家。CU在先进的工艺控制、生物反应器优化、基因组和转录组分析以及蛋白质糖基化方面拥有专业知识。UD提供系统和合成生物学方面的专业知识。UMD带来了传感器和监管科学方面的专业知识。UML提供流程开发、分析和产品表征方面的专业知识。通过将来自不同背景的学术研究人员和学生与工业和联邦合作伙伴聚集在一起，AMBIC致力于哺乳动物生物加工的技术创新，确保为患者开发和生产下一代挽救生命的生物药物。 该奖项由以下项目共同资助：工业大学合作研究中心计划在工业创新和伙伴关系的部门-工程理事会和系统和合成生物学计划在分子和细胞生物科学（MCB）的部门-该奖项反映了NSF的法定使命，并通过使用基金会的智力价值进行评估，被认为值得支持和更广泛的影响审查标准。