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

IUCRC 第二阶段：特拉华大学：先进哺乳动物生物制造创新中心 (AMBIC)

• 批准号: 2100502
• 负责人: Kelvin Lee
• 金额: $ 61.25万
• 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: 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=2100502&HistoricalAwards=false
• 关键词: IUCRC; Phase; II+; University; Delaware

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.

先进的哺乳动物生物制造创新中心（AMBIC）代表了在生产挽救生命的药物中维持国家卓越和美国技术领导力的独特机会。 Ambic是NSF支持的行业 - 大学合作研究中心（IUCRC），致力于使用动物细胞生产生物药物。 Ambic通过将来自五所大学（Johns Hopkins University（JHU），Clemson大学（CU），特拉华大学（UD），马里兰州大学公园（UMD）和马萨诸塞大学Lowell大学（UML）的洛厄尔大学（UML）限制了工业癌症的癌症和其他疾病的生产限制的重要性，重要的是，AMBIC通过将来自五所大学（Johns Hopkins University），克莱姆森大学（CU），克莱姆森大学（CU），特拉华大学（UD），特拉华大学（UD）限制了癌症和其他疾病的生产，重要的是重要的重要性的重要性，这是AMBIC的学术研究人员。工业研究人员共同开发解决方案，以提高这些变革性的进步，从而降低了降低消费者的卫生保健成本，从而使生物制药的负担得起，并通过跨阶段的II+促进了疗法。来自潜水员的生物技术和生物制药行业职业的背景。 Ambic的II阶段+研究目标的重点是：1）与工业相关的生物学，2）过程监测和控制，以及3）共识和标准化，用于推进上游生物制造。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和生产力。通过高级系统建模开发和实施新颖的分析工具，传感器和仪器，并且设计和部署了高级媒体和文化操作，以生成开发蛋白质和其他生物制剂的优化过程。 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。教师的研究人员是从五个大学地点吸引的，其中包括Cho生物学，代谢，动力学和热力学专家（JHU）的集中模型。 CU带来了高级过程控制，生物反应器优化，基因组和转录组分析以及蛋白质糖基化方面的专业知识。 UD提供了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在过程开发，分析和产品表征方面提供专业知识。通过将来自工业和联邦合作伙伴的潜水员背景的学术研究人员和学生汇集在一起​​，Ambic为哺乳动物生物处理的技术创新做出了贡献，以确保为患者的下一代挽救生命的生物药物的开发和制造。该奖项由以下计划共同资助：工业大学工业创新与伙伴关系部的行业合作研究中心计划 - 工程局以及分子和蜂窝生物科学部（MCB）的系统和合成生物学计划（MCB） - 生物学科学局 - 生物学董事董事奖，反映了NSF的诚实委员，这表明了NSF的诚实掌握，这是诚实的支持。 标准。

项目成果

Biopharmaceutical Manufacturing: Historical Perspectives and Future Directions

• DOI: 10.1146/annurev-chembioeng-092220-125832
• 发表时间: 2022-01-01
• 期刊: ANNUAL REVIEW OF CHEMICAL AND BIOMOLECULAR ENGINEERING
• 影响因子: 8.4
• 作者: Szkodny, Alana C.;Lee, Kelvin H.
• 通讯作者: Lee, Kelvin H.