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.
