NSF CMaT ERC Launches Hands-on Training in Cell Therapy Biomanufacturing
Outcome/Accomplishment
The National Science Foundation (NSF)-funded Engineering Research Center (ERC) for Cell Manufacturing Technologies (NSF CMaT) offers a unique virtual training course entitled, “The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory,” to train and retrain industry professionals. The course is made available in collaboration with the International Society for Cell & Gene Therapy (ISCT), a leading scientific society focused on translational aspects of developing cell-based therapeutics. In 2024, NSF CMaT launched its inaugural Hands-on Training Program at the Georgia Institute of Technology (Georgia Tech) to complement the virtual training course. NSF CMaT is based at Georgia Tech and the University of Georgia.
Impact/Benefits
Education and re-education of the existing biomanufacturing workforce is critical to the success of new advanced cell manufacturing-based therapies. The limited number of skilled workers has developed into a serious barrier for rapid growth and product development for companies and clinical manufacturing centers across the cell and gene therapy sector. Through the virtual and hands-on training programs offered by NSF CMaT, over 300 participants across the globe have been trained.
Explanation/Background
NSF CMaT began collaborations with ISCT on the development of a cell and gene therapy biomanufacturing professional training program in 2020. The goal of the program is to train a new workforce or retrain the existing workforce entering the field. The virtual training program is now well-established and offered multiple times per year. The curriculum consists of topics central to therapeutic cell manufacturing. Key topics in cell and gene therapy manufacturing and development are covered across four modules: (1) Stem Cell and Immune Cell Engineering and Therapies; (2) Quality Assurance and Regulatory Framework and Roundtable; (3) Cell Bioprocessing and Manufacturing Roundtable; and, (4) Cell Product Characterization and Importance of Standards. The modules include twelve asynchronous lectures; each lecture contains a theory component delivered by academic experts and an application component delivered by an industry expert. Through multiple live sessions corresponding to each module, participants can ask questions and clarify any content-related misconceptions.
The new Hands-on Training Program featured a week-long Bootcamp for Cell Therapy hosted at Georgia Tech’s Petit Institute for Bioengineering and Bioscience and the Marcus Center for Therapeutic Cell Characterization and Manufacturing. The Program included immersive sessions in both Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Participants are trained to initiate, maintain, scale up, and cryopreserve adherent and suspension cells using aseptic techniques and under GMP guidelines. Topics covered in the Bootcamp included Safety and Best Practices; Working with Cell Culture and Ensuring Purity; Advancing Cell Cultivation Techniques; the GMP Facility; and Mastering Cell Analysis Techniques. A second offering of the course took place in late 2024.
A blog post about the Inaugural Bootcamp is available online at: https://www.isctglobal.org/telegrafthub/blogs/lauren-reville/2024/05/16/the-inaugural-isct-cmat-hands-on-laboratory-bootca
Location
Atlanta, GeorgiaStart Year
Advanced Manufacturing
Advanced Manufacturing
Lead Institution
Core Partners
Fact Sheet
Outcome/Accomplishment
The National Science Foundation (NSF)-funded Engineering Research Center (ERC) for Cell Manufacturing Technologies (NSF CMaT) offers a unique virtual training course entitled, “The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory,” to train and retrain industry professionals. The course is made available in collaboration with the International Society for Cell & Gene Therapy (ISCT), a leading scientific society focused on translational aspects of developing cell-based therapeutics. In 2024, NSF CMaT launched its inaugural Hands-on Training Program at the Georgia Institute of Technology (Georgia Tech) to complement the virtual training course. NSF CMaT is based at Georgia Tech and the University of Georgia.
Location
Atlanta, GeorgiaStart Year
Advanced Manufacturing
Advanced Manufacturing
Lead Institution
Core Partners
Fact Sheet
Impact/benefits
Education and re-education of the existing biomanufacturing workforce is critical to the success of new advanced cell manufacturing-based therapies. The limited number of skilled workers has developed into a serious barrier for rapid growth and product development for companies and clinical manufacturing centers across the cell and gene therapy sector. Through the virtual and hands-on training programs offered by NSF CMaT, over 300 participants across the globe have been trained.
Explanation/Background
NSF CMaT began collaborations with ISCT on the development of a cell and gene therapy biomanufacturing professional training program in 2020. The goal of the program is to train a new workforce or retrain the existing workforce entering the field. The virtual training program is now well-established and offered multiple times per year. The curriculum consists of topics central to therapeutic cell manufacturing. Key topics in cell and gene therapy manufacturing and development are covered across four modules: (1) Stem Cell and Immune Cell Engineering and Therapies; (2) Quality Assurance and Regulatory Framework and Roundtable; (3) Cell Bioprocessing and Manufacturing Roundtable; and, (4) Cell Product Characterization and Importance of Standards. The modules include twelve asynchronous lectures; each lecture contains a theory component delivered by academic experts and an application component delivered by an industry expert. Through multiple live sessions corresponding to each module, participants can ask questions and clarify any content-related misconceptions.
The new Hands-on Training Program featured a week-long Bootcamp for Cell Therapy hosted at Georgia Tech’s Petit Institute for Bioengineering and Bioscience and the Marcus Center for Therapeutic Cell Characterization and Manufacturing. The Program included immersive sessions in both Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Participants are trained to initiate, maintain, scale up, and cryopreserve adherent and suspension cells using aseptic techniques and under GMP guidelines. Topics covered in the Bootcamp included Safety and Best Practices; Working with Cell Culture and Ensuring Purity; Advancing Cell Cultivation Techniques; the GMP Facility; and Mastering Cell Analysis Techniques. A second offering of the course took place in late 2024.
A blog post about the Inaugural Bootcamp is available online at: https://www.isctglobal.org/telegrafthub/blogs/lauren-reville/2024/05/16/the-inaugural-isct-cmat-hands-on-laboratory-bootca