Abstract
Stem cells have emerged as the starting material of choice for bioprocesses to produce cells and tissues to treat degenerative, genetic, and immunological disease. Translating the biological properties and potential of stem cells into therapies will require overcoming significant cell-manufacturing and regulatory challenges. Bioprocess engineering fundamentals, including bioreactor design and process control, need to be combined with cellular systems biology principles to guide the development of next-generation technologies capable of producing cell-based products in a safe, robust, and cost-effective manner. The step-wise implementation of these bioengineering strategies will enhance cell therapy product quality and safety, expediting clinical development.
Publication types
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Research Support, Non-U.S. Gov't
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Review
MeSH terms
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Biocompatible Materials / adverse effects
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Biocompatible Materials / standards
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Biomarkers, Pharmacological / metabolism*
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Bioreactors / supply & distribution
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Cell Differentiation
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Cell- and Tissue-Based Therapy / economics
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Cell- and Tissue-Based Therapy / instrumentation
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Cell- and Tissue-Based Therapy / methods
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Cost Control
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Drug Evaluation, Preclinical
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Embryonic Stem Cells* / cytology
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Embryonic Stem Cells* / metabolism
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Embryonic Stem Cells* / transplantation
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Gene Expression Profiling
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Guidelines as Topic / standards
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Humans
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Oligonucleotide Array Sequence Analysis
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Quality Control
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Quantitative Structure-Activity Relationship
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Stem Cell Transplantation* / economics
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Stem Cell Transplantation* / standards
Substances
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Biocompatible Materials
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Biomarkers, Pharmacological