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Stem Cells Transl Med. 2015 Oct;4(10):1155-63. doi: 10.5966/sctm.2014-0294. Epub 2015 Aug 27.

Concise Review: Process Development Considerations for Cell Therapy.

Author information

1
International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Thermo Fisher Scientific, Inc., Grand Island, New York, USA; Celgene Cellular Therapeutics, Warren, New Jersey, USA; Pluristem Therapeutics Inc., Haifa, Israel; Rooster Bio Inc., Frederick, Maryland, USA; Novartis Pharmaceuticals, Morris Plains, New Jersey, USA; Pall Life Sciences (division of Pall Corp), Port Washington, New York, USA; Stem Cell Group, Bioprocessing Technology Institute, A*STAR, Singapore, Singapore andrew.campbell@thermofisher.com.
2
International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Thermo Fisher Scientific, Inc., Grand Island, New York, USA; Celgene Cellular Therapeutics, Warren, New Jersey, USA; Pluristem Therapeutics Inc., Haifa, Israel; Rooster Bio Inc., Frederick, Maryland, USA; Novartis Pharmaceuticals, Morris Plains, New Jersey, USA; Pall Life Sciences (division of Pall Corp), Port Washington, New York, USA; Stem Cell Group, Bioprocessing Technology Institute, A*STAR, Singapore, Singapore.

Abstract

The development of robust and well-characterized methods of production of cell therapies has become increasingly important as therapies advance through clinical trials toward approval. A successful cell therapy will be a consistent, safe, and effective cell product, regardless of the cell type or application. Process development strategies can be developed to gain efficiency while maintaining or improving safety and quality profiles. This review presents an introduction to the process development challenges of cell therapies and describes some of the tools available to address production issues. This article will provide a summary of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization. The identification of the basic questions that affect process development is summarized in the target product profile, and considerations for process optimization are discussed. The goal is to identify potential manufacturing concerns early in the process so they may be addressed effectively and thus increase the probability that a therapy will be successful.

SIGNIFICANCE:

The present study contributes to the field of cell therapy by providing a resource for those transitioning a potential therapy from the research stage to clinical and commercial applications. It provides the necessary steps that, when followed, can result in successful therapies from both a clinical and commercial perspective.

KEYWORDS:

Cellular therapy; Mesenchymal stem cells; Pluripotent stem cells; Process development; T cell

PMID:
26315572
PMCID:
PMC4572896
DOI:
10.5966/sctm.2014-0294
[Indexed for MEDLINE]
Free PMC Article

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