Special Seminar: Improving Upstream Mammalian Cell Culture Biomanufacturing through the AMBIC Initiative

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Event Type: 
Contact Person: 
Zvi Kelman/Mike Tarlov
Event Info
Jul 21 2021 - 11:00am to 12:00pm
Michael J. Betenbaugh
Speaker Title: 
Director, Advanced Mammalian Biomanufacturing Innovation Center (AMBIC. Org) and Professor, Chemical and Biomolecular Engineering
Speaker Affiliation: 
Johns Hopkins University
Event Description: 

AMBIC (AMBIC.org) is a academic-government-industrial consortium dedicated to addressing early stage research and development challenges in upstream cell culture biomanufacturing.  Proposed areas of common interest are elucidated through summer workshops organized around the topical areas of cells, raw materials, processes, and equipment.  Industrial and federal mentors identify scientific and engineering bottlenecks that limit the production of pharmaceuticals used to treat cancer and other diseases, resulting in a call for proposal to academic members.  Academics then present proposals which are chosen to result in 2-year research and development projects that address these challenges under the guidance and mentorship of our industrial and government sponsors.  Academic, federal, and industrial researchers then work cooperatively to develop precompetitive solutions to improve the quantity and quality of biopharma products. These activities have resulted in the start-up and execution of over 30 active and graduated research projects under way at the academic participating institutions including Johns Hopkins University, University of Delaware, University of Massachusetts, Lowell, Clemson University, and University of Maryland, College Park. Focal areas of the center include:  1) understanding industrially-relevant biology, 2) process monitoring and control, and 3) consensus and standardization for advancing upstream biomanufacturing.   This presentation will discuss the activities of the AMBIC center followed by an overview of the projects and progress underway within AMBIC.  Active projects include efforts to develop standardized community reference cell lines, process, and media for production of recombinant proteins and gene therapy products.   Cell line stability, robustness, and productivity are being investigated for Chinese hamster ovary (CHO) and other industrial mammalian hosts. Novel analytic tools, sensors, and instrumentation are being developed and implemented for characterizing and optimizing biomanufacturing processes.  Other projects include understanding and characterizing the epigenome,  identification of inhibitory waste products, adaptation of process models for cell culture media and process feeding, elucidation of inhibitory metabolic pathways, production of extracellular vesicles, identification of ER stress pathways, and evaluation of nutrient solubility and chemical complexation. AMBIC industrial members include large integrated biopharma companies, manufacturers, suppliers, and consultants.  Government participants include NIST along with NSF, who supports operations for the consortium. By bringing together a community of academic, government, and industrial partners, AMBIC is leading technology standardization and innovation in early stage mammalian biomanufacturing, ensuring the development and implementation of the next generation of life saving biologic medicines for patients who need them.


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