Biomanufacturing of Therapeutic Cells: State of the Art, Current Challenges, and Future Perspectives

• Published in: Annual review of chemical and biomolecular engineering Vol. 7; no. 1; pp. 455 - 478
• Main Authors: Roh, Kyung-Ho, Nerem, Robert M, Roy, Krishnendu
• Format: Journal Article
• Language: English
• Published: United States Annual Reviews 07.06.2016
• Subjects: Activation; biomanufacturing; Bioreactors; Biotechnology; Cell Culture Techniques - instrumentation; Cell Culture Techniques - methods; cell therapy; Cell- and Tissue-Based Therapy; Cures; Disorders; Humans; Neoplasms - therapy; Nervous System Diseases - therapy; Packaging; Purification; Regenerative Medicine; scale-out; scale-up; State of the art; stem cell; Stem Cell Transplantation; Stem cells; Stem Cells - cytology; Stem Cells - metabolism; T cell; T-Lymphocytes - cytology; T-Lymphocytes - metabolism; T-Lymphocytes - transplantation; biomanufacturing; scale-up; scale-out; stem cell; T cell; cell therapy
• ISSN: 1947-5438; 1947-5446
• DOI: 10.1146/annurev-chembioeng-080615-033559

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.