Phase I IUCRC at Maryland: Advanced Mammalian Biomanufacturing Innovation Center (AMBIC)

胰岛素或癌症靶向抗体等生物药物是由生物来源(包括转基因活细胞)生产的救命药物。重要的是，这些复杂的分子不能通过自动化的合成化学过程来制造。取而代之的是，它们可以由在生物反应器中生长的细胞进行生物制造。先进哺乳动物生物制造创新中心(AMBIC)正在开发使能技术、知识、设计工具和方法，以快速跟踪生物制造的进展。AMBIC是一个由公司、学术机构和联邦机构组成的行业领先联盟，正在通过注入解决方案来应对与生物制造相关的挑战，这些解决方案可以提高速度、可靠性、可预测性和产品质量(包括安全性和有效性)，同时保持灵活性并潜在地降低成本。AMBIC有三个主要的研究重点：(I)了解与工业相关的生物学，以便制造实践能够利用这一新兴知识来控制生物过程，以实现最佳的生物制药生产；(Ii)能够简化和有效制造操作的先进过程监测和控制系统；以及(Iii)创建共识的行业范围的最佳实践和标准，以最有效地利用制造投入，以便产品能够容易地通过监管检查和审查。这样，美国的健康和安全就会受到积极的影响。随着AMBIC研究人员开发新的和增强的生产工艺、细胞系、细胞生长介质和过程分析技术，马里兰大学(UMD)网站内最先进的生物处理套件将被用作公认的试验台，并与国家标准与技术研究所(NIST)联合。AMBIC研究人员还将与马里兰州监管科学和创新卓越中心(M-CERSI)合作，M-CERSI是与美国食品和药物管理局(FDA)联合成立的监管科学研究中心。数十家生物制药公司的生物治疗产品受到FDA的监管，并依赖于NIST允许的标准和测量。UMD网站有助于将这些联邦机构整合到AMBIC中心。UMD网站还将带来强大的新分析方法，包括无线实时过程数据采集和现场产品测量工具，用于嵌入先进的反应堆控制方法。也许最重要的是，来自不同学术背景(化学、材料科学、化学和生物工程、过程控制)的不同学生致力于推动制造实践，将很容易被该行业接受，并将成为其未来的催化剂。随着AMBIC的发展，由于美国各地的许多参与者共同努力规划未来，它将成为未来20年美国生物制造的焦点。该奖项由以下项目共同资助：化学生化环境和运输部(CBET)的细胞和生化工程计划-工程(ENG)目录。分子和细胞生物科学部(MCB)-生物科学委员会的系统和合成生物学计划。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

Biopharmaceuticals, such as insulin or cancer-targeting antibodies, are life-saving medicines that are 'bio'manufactured from biological sources, including genetically-modified living cells. Importantly, these complex molecules cannot be manufactured by automated synthetic chemical processes. Instead, they can be biomanufactured by cells optimally grown in bioreactors. The Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) is developing enabling technologies, knowledge, design tools and methods that fast-track advances in biomanufacturing. AMBIC is an industry-led consortium of companies, academic institutions, and federal agencies that is addressing biomanufacturing-related challenges by injecting solutions that enhance speed, reliability, predictability, and product quality (including safety and efficacy), while maintaining flexibility and potentially lowering cost. There are three main research thrusts within AMBIC: (i) understanding industrially-relevant biology so that manufacturing practices can leverage this emerging knowledge to control biological processes for optimal biopharmaceuticals production, (ii) advanced process monitoring and control systems that enable streamlined and effective manufacturing operations, and (iii) creating consensus industry-wide best practices and standards to most effectively utilize manufacturing inputs so that products will readily pass regulatory inspection and review. In this way, the health and security of the US are positively impacted. As AMBIC investigators develop new and enhanced production processes, cell lines, cell growth media, and process analytical technologies, a state-of-the-art bioprocessing suite within the University of Maryland (UMD) Site and joint with the National Institute of Standards and Technology (NIST) will be used as a recognized testbed. AMBIC researchers will also work with Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI), a regulatory science research center joint with the U.S. Food and Drug Administration. Scores of biopharmaceuticals companies have biotherapeutics products that are regulated by the FDA and rely on standards and measurements enabled by NIST. The UMD Site helps to integrate these federal agencies into the AMBIC center. The UMD Site will also bring powerful new analytical methodologies including wireless real time process data acquisition and in situ product measurement tools for embedding into advanced reactor control methodologies. Perhaps most importantly, a diverse set of students from a variety of academic backgrounds (chemistry, materials science, chemical and bioengineering, process control) working to advance manufacturing practice will be readily accepted by the industry and will be the catalyst for its future. As AMBIC grows, owing to many participants throughout the US working together to chart the future, it will be a focal point for U.S. biomanufacturing for the next two decades.This award is co-funded by the following Programs:Cellular & Biochemical Engineering Program in the Division of Chemical Biochemical Environment and Transport (CBET) - Engineering (ENG) Directorate.Systems and Synthetic Biology Program in the Division of Molecular and Cellular Biosciences (MCB) - Biological Sciences Directorate .This 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.