Phase I I/UCRC Clemson University Site: Advanced Mammalian Biomanufacturing Innovation Center (AMBIC)

I 期 I/UCRC 克莱姆森大学基地：先进哺乳动物生物制造创新中心 (AMBIC)

• 批准号: 1624641
• 负责人: Sarah Harcum
• 金额: $ 75万
• 依托单位: Clemson University
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1624641&HistoricalAwards=false
• 关键词: Phase; UCRC; Clemson; University; Site

Phase I I/UCRC Clemson University Site: Advanced Mammalian Biomanufacturing Innovation Center (AMBIC).Johns Hopkins University, University of Delaware, Clemson University, and University of Massachusetts-Lowell have jointly established a multi-university, Phase I I/UCRC entitled the Advanced Mammalian Biomanufacturing Innovation Center (AMBIC). Over the past two decades, the biopharmaceutical industry has emerged as one of the major manufacturing industries and engines of growth in the US economy. Biomanufacturing represents nearly 2% of the total US GDP and its fraction is expanding. Much of biomanufacturing involves the use of cells to make medicines. Examples of these types of medicines include cancer medicines and vaccines. A key element in developing these medicines is the need to establish complex manufacturing processes. AMBIC will implement engineering innovations to enhance the capabilities of our nation to manufacture these important life-extending and life-saving medicines. Such improvements will improve the competitiveness of US biomanufacturing in coming decades leading to more economic investment by these companies and more jobs for American workers. The mission of AMBIC is to develop enabling technologies, knowledge, design tools and methods that apply and integrate high-throughput and genome-based technologies to fast-track advanced biomanufacturing processes. AMBIC is the first I/UCRC dedicated to mammalian cell culture upstream development focusing on Chinese hamster ovary (CHO) cells, the principal biopharmaceutical production host of industry. AMBIC will bring together leading academic and industrial biotechnologists focused on mammalian cell culture manufacturing at a pre-competitive research level to address the complex problems in biopharmaceutical manufacturing. This multi-university center will allow AMBIC to leverage the skills and the expertise of many faculty members across the Sites. AMBIC will be a critical catalyst towards maintaining national excellence in biopharmaceutical production by conducting research in: 1) Understanding Industrially-Relevant Biology (e.g., all -omics, bioinformatics, process and product quality, etc.); 2) Process Monitoring & Control (e.g., analytics, instrumentation, data mining and modeling); 3) Consensus and Standardization Issues (e.g., standards, simple fingerprints, raw material issues, regulatory issues, forensic bioprocessing, clonality). Through systems-level biology analysis, novel cell line development, bioreactor optimization, and advanced analytics, AMBIC will provide transformative solutions that can lower biomanufacturing costs and improve bioprocessing efficiency. Most importantly, these advances may ultimately serve to make more biopharmaceuticals available to patients that need them and lower overall health care costs for consumers. In addition, AMBIC will establish and maintain a pipeline of educated and motivated students at multiple levels for careers in biopharmaceutical manufacturing and development. Collaborations with corporate partners will enable the students to work on the most pressing problems that the industry faces. Furthermore, this center will serve to engage and excite students from under-represented minority populations to pursue a career in life sciences, engineering, or related STEM fields. An important part of the AMBIC activities and a committed goal of the PI's is to increase the participation of women and under-represented minorities in STEM disciplines by energizing students from all backgrounds about the exciting opportunities to help others through STEM careers in biotechnology and biomedicine.

I期I/UCRC克莱姆森大学基地：高级哺乳动物生物制造创新中心（AMBIC）约翰霍普金斯大学、特拉华州大学、克莱姆森大学和马萨诸塞大学洛厄尔分校联合建立了一个多大学的I期I/UCRC，名为高级哺乳动物生物制造创新中心（AMBIC）。 在过去的二十年里，生物制药行业已经成为美国经济增长的主要制造业和引擎之一。 生物制造业占美国GDP总量的近2%，其份额正在扩大。许多生物制造涉及使用细胞来制造药物。 这类药物的例子包括癌症药物和疫苗。开发这些药物的一个关键因素是需要建立复杂的制造工艺。AMBIC将实施工程创新，以提高我们国家生产这些重要的延长生命和拯救生命药物的能力。 这些改进将在未来几十年内提高美国生物制造业的竞争力，从而导致这些公司的更多经济投资和美国工人的更多就业机会。AMBIC的使命是开发使能技术、知识、设计工具和方法，应用和整合高通量和基于基因组的技术，以快速跟踪先进的生物制造过程。 AMBIC是第一个致力于哺乳动物细胞培养上游开发的I/UCRC，专注于中国仓鼠卵巢（CHO）细胞，这是行业的主要生物制药生产宿主。 AMBIC将汇集领先的学术和工业生物技术专家，专注于竞争前研究水平的哺乳动物细胞培养制造，以解决生物制药制造中的复杂问题。 这个多所大学的中心将使AMBIC能够利用各地许多教师的技能和专业知识。 AMBIC将通过以下方面的研究成为保持国家生物制药生产卓越性的关键催化剂：1）了解工业相关生物学（例如，全组学、生物信息学、工艺和产品质量等）; 2)过程监测控制（例如，分析、仪器、数据挖掘和建模）; 3）共识和标准化问题（例如，标准、简单指纹、原材料问题、监管问题、法医生物处理、克隆性）。 通过系统级生物学分析、新型细胞系开发、生物反应器优化和高级分析，AMBIC将提供变革性的解决方案，降低生物制造成本，提高生物加工效率。 最重要的是，这些进展最终可能有助于为需要的患者提供更多生物制药，并降低消费者的整体医疗保健成本。 此外，AMBIC将建立和维护一个多层次的受过教育和有动力的学生的管道，以从事生物制药制造和开发。 与企业合作伙伴的合作将使学生能够解决行业面临的最紧迫的问题。 此外，该中心将致力于吸引和激励来自代表性不足的少数民族人口的学生从事生命科学，工程或相关STEM领域的职业。 AMBIC活动的一个重要组成部分和PI的一个承诺目标是通过激励来自各种背景的学生通过生物技术和生物医学的STEM职业帮助他人的令人兴奋的机会来增加妇女和代表性不足的少数民族在STEM学科的参与。

项目成果

Rapid metal speciation of cell culture media using reversed‐phase separations and inductively coupled plasma optical emission spectrometry

• DOI: 10.1002/btpr.3311
• 发表时间: 2022-10
• 期刊: Biotechnology Progress
• 影响因子: 2.9
• 作者: Sarah K. Wysor;Katja A. Hall;R. K. Marcus

Induced pluripotent stem cells can utilize lactate as a metabolic substrate to support proliferation

• DOI: 10.1002/btpr.3090
• 发表时间: 2020-11-04
• 期刊: BIOTECHNOLOGY PROGRESS
• 影响因子: 2.9
• 作者: Odenwelder, Daniel C.;Lu, Xiaoming;Harcum, Sarah W.
• 通讯作者: Harcum, Sarah W.

Sensitive real-time on-line estimator for oxygen transfer rates in fermenters

发酵罐中氧气传输率的灵敏实时在线估算器

• DOI: 10.1016/j.jbiotec.2022.09.005
• 发表时间: 2022
• 期刊: Journal of Biotechnology
• 影响因子: 4.1
• 作者: Trout, Marshall;Harcum, Sarah W.;Groff, Richard E.
• 通讯作者: Groff, Richard E.

Generation of reference cell lines, media, and a process platform for CHO cell biomanufacturing

生成用于 CHO 细胞生物制造的参考细胞系、培养基和工艺平台

• DOI: 10.1002/bit.28290
• 发表时间: 2022
• 期刊: Biotechnology and Bioengineering
• 影响因子: 3.8
• 作者: Cordova, Lauren T.;Dahodwala, Hussain;Elliott, Kathryn S.;Baik, Jongyoun;Odenewelder, Daniel C.;Nmagu, Douglas;Skelton, Bradley A.;Uy, Lisa;Klaubert, Stephanie R.;Synoground, Benjamin F.
• 通讯作者: Synoground, Benjamin F.