Abstract
This review presents an introduction to the process development challenges of cell therapies and describes some of the tools available to address production issues. A summary is provided of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization.
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Details
1 International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Thermo Fisher Scientific, Inc., Grand Island, New York, USA
2 International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Celgene Cellular Therapeutics, Warren, New Jersey, USA
3 International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Pluristem Therapeutics Inc., Haifa, Israel
4 International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Rooster Bio Inc., Frederick, Maryland, USA
5 International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Novartis Pharmaceuticals, Morris Plains, New Jersey, USA
6 International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Pall Life Sciences (division of Pall Corp), Port Washington, New York, USA
7 International Society for Cellular Therapy Process and Product Development Subcommittee, Vancouver, British Columbia, Canada; Stem Cell Group, Bioprocessing Technology Institute, A*STAR, Singapore, Singapore