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

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命药物方面的技术领先地位。AMBIC是一个由美国国家科学基金会支持的产学研合作研究中心（IUCRC），专注于利用动物细胞生产生物药物。AMBIC作为技术创新的催化剂，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）、马里兰大学帕克分校（UMD）和马萨诸塞大学洛厄尔分校（UML）的学术研究人员。工业和联邦顾问指出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。接下来，学术界、联邦政府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。这些变革性的进步可能会加速药品上市并降低制造成本，通过使生物药品更容易负担和获得，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+期期间得到了领先的生物制药公司和供应商公司以及联邦研究所的支持。AMBIC通过培养不同背景的学生从事生物技术和生物制药行业的职业，为科学界做出了贡献。AMBIC II+阶段的研究目标集中在：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和其他工业哺乳动物宿主细胞系的稳定性、稳健性和生产力。新的分析工具、传感器和仪器被开发和实施，先进的系统建模和先进的培养基和培养操作被设计和部署，以产生优化的过程，用于开发蛋白质和其他生物制剂。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。学院研究人员来自五个大学站点，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带来了先进的过程控制，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。特拉华大学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提供了过程开发、分析和产品特性方面的专业知识。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拯救生命的生物药物。该奖项由以下项目共同资助：工业创新和伙伴关系部门的工业大学合作研究中心项目-工程理事会和分子和细胞生物科学部（MCB）的系统和合成生物学项目-生物科学理事会该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.