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

I 期 I/UCRC 特拉华大学基地：先进哺乳动物生物制造创新中心 (AMBIC)

• 批准号: 1624698
• 负责人: Kelvin Lee
• 金额: $ 75万
• 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: 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=1624698&HistoricalAwards=false
• 关键词: Phase; UCRC; University; Delaware; Site

Phase I I/UCRC University of Delaware 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.

第一阶段I/UCRC特拉华大学网站：高级哺乳动物生物制造创新中心（AMBIC）。约翰斯·霍普金斯大学，特拉华大学，克莱姆森大学，克莱姆森大学和马萨诸塞州 - 洛威尔大学共同建立了一个多元大学，I/UCRC，具有先进的哺乳动物生物制造公司（Ambianov Innocation Innoveration Innoveration Innocation Innocation Innocation Innocation Innocation Innocation Center）。在过去的二十年中，生物制药行业已成为美国经济增长的主要制造业和发动机之一。生物制造占美国国内生产总值的近2％，其部分占用的分数正在扩大。大部分生物制造涉及使用细胞制造药物。这些类型的药物的例子包括癌症药物和疫苗。开发这些药物的关键要素是建立复杂的制造过程。 Ambic将实施工程创新，以增强我们国家制造这些重要的寿命和挽救生命的药物的能力。这种改进将在未来几十年中提高美国生物制造的竞争力，从而导致这些公司的更多经济投资，并为美国工人提供更多的就业机会。Ambic的使命是开发促进技术，知识，设计工具和方法，以应用和整合基于高知识和基因组的技术，以便快速传播生物制造过程。 Ambic是第一个专门针对上游开发的哺乳动物细胞培养的I/UCRC，重点是中国仓鼠卵巢（CHO）细胞，这是主要的生物制药生产。 Ambic将召集领先的学术和工业生物技术医生，专注于竞争力的研究水平，以解决哺乳动物细胞培养的生产，以解决生物制药制造中的复杂问题。这个多元大学中心将使Ambic能够利用网站上许多教师的技能和专业知识。 AMBIC将通过进行研究：1）了解与工业相关的生物学（例如，所有 - 组，生物信息学，过程和产品质量等）来维持生物制药生产的全国性卓越的关键催化剂； 2）过程监视与控制（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，简单的指纹，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，新颖的细胞系开发，生物反应器优化和高级分析，AMBIC将提供变革性的解决方案，以降低生物制造成本并提高生物处理效率。最重要的是，这些进步最终可能有助于使需要它们的患者使用更多的生物药物，并降低消费者的总体医疗保健成本。此外，Ambic将建立并维护受过教育和有动力的学生在多个层面上为生物制药制造和开发的职业提供的管道。与公司合作伙伴的合作将使学生能够解决行业面临的最紧迫问题。此外，该中心将有助于吸引和激发代表性不足的少数群体的学生，从而从事生命科学，工程或相关STEM领域的职业。 AMBIC活动的重要组成部分以及PI的目标是通过向来自各种背景的学生充满活力，以帮助他人通过生物技术和生物医学的STEM职业来帮助他人，从而增加妇女和代表性不足的少数民族参与STEM学科的参与。

项目成果

Host Cell Proteins During Biomanufacturing

生物制造过程中的宿主细胞蛋白质

• 发表时间: 2019
• 期刊: Current applications of cell culture engineering
• 作者: Baik, J.Y.;Guo, J.;Lee, K.H.
• 通讯作者: Lee, K.H.

Creation of monoclonal antibody expressing CHO cell lines grown with sodium butyrate and characterization of resulting antibody glycosylation

• DOI: 10.1016/bs.mie.2021.06.039
• 发表时间: 2021-01-01
• 期刊: RECOMBINANT PROTEIN EXPRESSION: EUKARYOTIC HOSTS
• 作者: Nmagu, Douglas;Singh, Sumit K.;Lee, Kelvin H.
• 通讯作者: Lee, Kelvin H.

Comprehensive assessment of host cell protein expression after extended culture and bioreactor production of CHO cell lines

CHO细胞系扩展培养和生物反应器生产后宿主细胞蛋白表达的综合评估

• DOI: 10.1002/bit.28128
• 发表时间: 2022
• 期刊: Biotechnology and Bioengineering
• 影响因子: 3.8
• 作者: Hamaker, Nathaniel K.;Min, Lie;Lee, Kelvin H.
• 通讯作者: Lee, Kelvin H.

The fickle CHO: a review of the causes, implications, and potential alleviation of the CHO cell line instability problem

• DOI: 10.1016/j.copbio.2019.01.011
• 发表时间: 2019-12-01
• 期刊: CURRENT OPINION IN BIOTECHNOLOGY
• 影响因子: 7.7
• 作者: Dahodwala, Hussain;Lee, Kelvin H.
• 通讯作者: Lee, Kelvin H.

Growth Rate Changes in CHO Host Cells Are Associated with Karyotypic Heterogeneity

• DOI: 10.1002/biot.201700230
• 发表时间: 2018-03-01
• 期刊: BIOTECHNOLOGY JOURNAL
• 影响因子: 4.7
• 作者: Baik, Jong Youn;Lee, Kelvin H.
• 通讯作者: Lee, Kelvin H.