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

生物制药，如胰岛素或癌症靶向抗体，是用生物来源（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来生物制造。高级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步。AMBIC是一个由行业主导的公司、学术机构和联邦机构组成的联盟，致力于通过注射解决方案来解决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），同时保持灵活性和潜在的低成本。AMBIC有三个主要的研究重点：(i)了解工业相关的生物学，以便生产实践可以利用这些新兴的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，使生产操作流程化和有效；（iii）创建全行业的共识最佳实践和标准，以最有效地利用生产投入，使产品容易通过监管检查和审查。这将对美国的健康和安全产生积极影响。随着AMBIC研究人员开发新的和增强的生产工艺、细胞系、细胞生长介质和过程分析技术，马里兰大学（UMD）基地内最先进的生物处理套件将与国家标准与技术研究所（NIST）联合使用，作为公认的试验台。AMBIC的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，这是一个与美国食品和药物管理局（fda）联合设立的监管科学研究中心。许多生物制药公司的生物治疗产品受FDA监管，并依赖于NIST提供的标准和测量。UMD网站帮助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）的多样化学生将很容易被行业所接受，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年美国生物制造业的焦点。该奖项由以下项目共同资助：化学生化环境与运输（CBET）部门的细胞与生化工程项目-工程（ENG）理事会。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知识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.