Format

Send to

Choose Destination
Nat Biomed Eng. 2018 Jun;2(6):362-376. doi: 10.1038/s41551-018-0246-6. Epub 2018 Jun 11.

Biomanufacturing for clinically advanced cell therapies.

Author information

1
Department of Biomedical Engineering, Rutgers University, Piscataway, NJ, USA.
2
Department of Surgery, Center for Surgery, Innovation, and Bioengineering, Massachusetts General Hospital, Harvard Medical School and Shriners Hospitals for Children, Boston, MA, USA.
3
Hitachi Chemical Advanced Therapeutics Solutions, Allendale, NJ, USA.
4
Department of Chemical Engineering, Institute for Medical Engineering and Science, Division of Health Science and Technology, and the David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA.
5
Cancer Institute of New Jersey, New Brunswick, NJ, USA.
6
Human Genetics Institute of New Jersey, RUCDR, Piscataway, NJ, USA.
7
Cellular Immunotherapy Program, Cancer Center, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
8
BlueRock Therapeutics, Cambridge, MA, USA.
9
Sentien Biotechnologies, Inc, Lexington, MA, USA.
10
Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
11
Harvard Stem Cell Institute, Cambridge, MA, USA.
12
Department of Biomedical Engineering, Rutgers University, Piscataway, NJ, USA. biju_parekkadan@hms.harvard.edu.
13
Department of Surgery, Center for Surgery, Innovation, and Bioengineering, Massachusetts General Hospital, Harvard Medical School and Shriners Hospitals for Children, Boston, MA, USA. biju_parekkadan@hms.harvard.edu.
14
Sentien Biotechnologies, Inc, Lexington, MA, USA. biju_parekkadan@hms.harvard.edu.
15
Harvard Stem Cell Institute, Cambridge, MA, USA. biju_parekkadan@hms.harvard.edu.

Abstract

The achievements of cell-based therapeutics have galvanized efforts to bring cell therapies to the market. To address the demands of the clinical and eventual commercial-scale production of cells, and with the increasing generation of large clinical datasets from chimeric antigen receptor T-cell immunotherapy, from transplants of engineered haematopoietic stem cells and from other promising cell therapies, an emphasis on biomanufacturing requirements becomes necessary. Robust infrastructure should address current limitations in cell harvesting, expansion, manipulation, purification, preservation and formulation, ultimately leading to successful therapy administration to patients at an acceptable cost. In this Review, we highlight case examples of cutting-edge bioprocessing technologies that improve biomanufacturing efficiency for cell therapies approaching clinical use.

PMID:
31011198
PMCID:
PMC6594100
DOI:
10.1038/s41551-018-0246-6
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for PubMed Central
Loading ...
Support Center