CMaT's Redesigned "Engineering Concepts in Therapeutic Cell Manufacturing" Course Successfully Trains Graduate Students for Cell Manufacturing Careers
Outcome/Accomplishment
Dr. Shalu Suri of the Cell Manufacturing Technologies (CMaT) Engineering Research Center (ERC) at the Georgia Institute for Technology successfully led the Center's redesigned, multi-institution course focused on technical issues in cell manufacturing in Fall 2020. The graduate-level course, "Engineering Concepts in Therapeutic Cell Manufacturing," features perspectives from industry partners and governmental leaders. The CMaT ERC is funded by the National Science Foundation (NSF).
Impact/Benefits
CMaT's multi-institution course provides a graduate-level foundation in the biology of therapeutic cells—especially stem and progenitor cells, stromal cells, and immune cells—and the engineering and manufacturing approaches to developing scalable manufacturing platforms with these cells and their derivatives. The course emphasizes application of analytical engineering approaches for the quantitative study of stem/immune cell biology and effective translation of cells into industrial-scale therapies and diagnostics. Students are led through the conceptual process of identifying an appropriate type of therapeutic cell, based on functional attributes for a desired application; then, they examine various aspects of cell manufacturing as well as industrial translation and regulatory processes that should be considered to bring the concept to clinical application.
Explanation/Background
Experts assert that the cell and gene therapy production industry does not leverage sophisticated techniques and accepted standards to control and assure product consistency and quality, as normally occurs with the manufacture of other goods. The CMaT graduate-level course was redesigned to better address this challenge.
Learning objectives for the course included: providing a graduate-level foundation on principles governing therapeutic cell manufacturing; discussing the elements of quality control, quality by design, cell manufacturing unit operations, and the relationship between process development, critical quality attributes (CQAs), and critical process parameters (CPPs); developing an understanding of bioprocessing approaches for the effective translation of cells into industrial-scale therapies; discussing the importance of standards in cell manufacturing; learning about regulatory issues in cell therapy translation; and enabling graduate students with the necessary biological and engineering background to successfully conduct research with therapeutic cells. The overall goal for the course is to lay the foundation for a potential professional career in cell manufacturing.
Thirty-five students from four primary CMaT campuses—Georgia Institute of Technology, the University of Georgia, the University of Puerto Rico-Mayaguez, and the University of Wisconsin-Madison—attended the Fall 2020 course virtually. Industry perspectives were provided by Taby Ahsan of RoosterBio, Surendra Chavan of ViCapsys, Eytan Abraham of Lonza, and Greg Russotti of Century Therapeutics. Government perspectives included contributions from Sheng-Lin Gibson of the National Institute for Standards and Technology (NIST) and Iris Marklein of the Food and Drug Administration (FDA).
Location
Atlanta, Georgiawebsite
Start Year
Advanced Manufacturing
Lead Institution
Core Partners
Fact Sheet
Outcome/Accomplishment
Dr. Shalu Suri of the Cell Manufacturing Technologies (CMaT) Engineering Research Center (ERC) at the Georgia Institute for Technology successfully led the Center's redesigned, multi-institution course focused on technical issues in cell manufacturing in Fall 2020. The graduate-level course, "Engineering Concepts in Therapeutic Cell Manufacturing," features perspectives from industry partners and governmental leaders. The CMaT ERC is funded by the National Science Foundation (NSF).
Location
Atlanta, Georgiawebsite
Start Year
Advanced Manufacturing
Lead Institution
Core Partners
Fact Sheet
Impact/benefits
CMaT's multi-institution course provides a graduate-level foundation in the biology of therapeutic cells—especially stem and progenitor cells, stromal cells, and immune cells—and the engineering and manufacturing approaches to developing scalable manufacturing platforms with these cells and their derivatives. The course emphasizes application of analytical engineering approaches for the quantitative study of stem/immune cell biology and effective translation of cells into industrial-scale therapies and diagnostics. Students are led through the conceptual process of identifying an appropriate type of therapeutic cell, based on functional attributes for a desired application; then, they examine various aspects of cell manufacturing as well as industrial translation and regulatory processes that should be considered to bring the concept to clinical application.
Explanation/Background
Experts assert that the cell and gene therapy production industry does not leverage sophisticated techniques and accepted standards to control and assure product consistency and quality, as normally occurs with the manufacture of other goods. The CMaT graduate-level course was redesigned to better address this challenge.
Learning objectives for the course included: providing a graduate-level foundation on principles governing therapeutic cell manufacturing; discussing the elements of quality control, quality by design, cell manufacturing unit operations, and the relationship between process development, critical quality attributes (CQAs), and critical process parameters (CPPs); developing an understanding of bioprocessing approaches for the effective translation of cells into industrial-scale therapies; discussing the importance of standards in cell manufacturing; learning about regulatory issues in cell therapy translation; and enabling graduate students with the necessary biological and engineering background to successfully conduct research with therapeutic cells. The overall goal for the course is to lay the foundation for a potential professional career in cell manufacturing.
Thirty-five students from four primary CMaT campuses—Georgia Institute of Technology, the University of Georgia, the University of Puerto Rico-Mayaguez, and the University of Wisconsin-Madison—attended the Fall 2020 course virtually. Industry perspectives were provided by Taby Ahsan of RoosterBio, Surendra Chavan of ViCapsys, Eytan Abraham of Lonza, and Greg Russotti of Century Therapeutics. Government perspectives included contributions from Sheng-Lin Gibson of the National Institute for Standards and Technology (NIST) and Iris Marklein of the Food and Drug Administration (FDA).