Biomanufacturing of Therapeutic Cells: State of the Art, Current Challenges, and Future Perspectives.
Stem cells and other functionally defined therapeutic cells (e.g., T cells) are promising to bring hope of a permanent cure for diseases and disorders that currently cannot be cured by conventional drugs or biological molecules. This paradigm shift in modern medicine of using cells as novel therapeutics can be realized only if suitable manufacturing technologies for large-scale, cost-effective, reproducible production of high-quality cells can be developed. Here we review the state of the art in therapeutic cell manufacturing, including cell purification and isolation, activation and differentiation, genetic modification, expansion, packaging, and preservation. We identify current challenges and discuss opportunities to overcome them such that cell therapies become highly effective, safe, and predictively reproducible while at the same time becoming affordable and widely available.
The Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory, Atlanta, Georgia 30332-0313; email: krish.roy@gatech.edu.|The Parker H. Petit Institute for Bioengineering and Biosciences, Georgia Institute of Technology, Atlanta, Georgia 30332.
Kyung-Ho
KH
Roh
The Parker H. Petit Institute for Bioengineering and Biosciences, Georgia Institute of Technology, Atlanta, Georgia 30332.|The George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, Georgia 30332.
Robert M
RM
Nerem
The Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory, Atlanta, Georgia 30332-0313; email: krish.roy@gatech.edu.|The Parker H. Petit Institute for Bioengineering and Biosciences, Georgia Institute of Technology, Atlanta, Georgia 30332.
Krishnendu
K
Roy
D019149:Bioreactors; D018929:Cell Culture Techniques / Q000295:instrumentation / Q000379:methods; D064987:Cell- and Tissue-Based Therapy; D006801:Humans; D009369:Neoplasms / Q000628:therapy; D009422:Nervous System Diseases / Q000628:therapy; D044968:Regenerative Medicine; D033581:Stem Cell Transplantation; D013234:Stem Cells / Q000166:cytology* / Q000378:metabolism; D013601:T-Lymphocytes / Q000166:cytology* / Q000378:metabolism / Q000637:transplantation
T cell; biomanufacturing; cell therapy; scale-out; scale-up; stem cell