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

生物制药，例如胰岛素或癌症靶向抗体，是由生物来源（包括转基因活细胞）“生物”制造的救命药物。重要的是，这些复杂的分子不能通过自动化合成化学过程来制造。相反，它们可以通过在生物反应器中最佳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）正在开发可快速跟踪生物制造进步的支持技术、知识、设计工具和方法。 AMBIC 是一个由行业领先的公司、学术机构和联邦机构组成的联盟，致力于通过注入提高速度、可靠性、可预测性和产品质量（包括安全性和有效性）的解决方案来应对生物制造相关的挑战，同时保持灵活性并可能降低成本。 AMBIC 内有三个主要研究方向：(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) 先进的过程监测和控制系统，实现简化和有效的制造操作；(iii) 建立全行业共识的最佳实践和标准，以最有效地利用制造投入，使产品能够轻松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、细胞生长培养基和工艺分析技术，马里兰大学 (UMD) 站点内并与国家标准与技术研究所 (NIST) 联合的最先进的生物处理套件将被用作公认的测试平台。 AMBIC 研究人员还将与马里兰州监管科学与创新卓越中心 (M-CERSI) 合作，该中心是与美国食品和药物管理局联合设立的监管科学研究中心。许多生物制药公司都拥有受 FDA 监管的生物治疗产品，并依赖 NIST 制定的标准和测量。 UMD 站点有助于将这些联邦机构整合到 AMBIC 中心。 UMD 站点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用于嵌入先进反应堆控制方法的现场产品测量工具。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、致力于推进制造实践的多元化学生将很容易被行业接受，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，它将成为未来二十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门 (CBET) - 工程 (ENG) 理事会的细胞与生化工程项目。分子和细胞生物科学 (MCB) 部门的系统和合成生物学项目 - 生物科学理事会该奖项反映了 NSF 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。

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.