Challenges and Opportunities in the Development of Induced Pluripotent Stem Cell Therapeutics

- Authors: James A. Smith1,2, Anna French3, Hannah Hurley4,5, Benjamin Davies6,7, Sue Dopson8, Paul Fairchild9, Mackenna Roberts10, Paul Riley11, Brock Reeve12, David Williams13, Laurence Daheron14, Kim Bure15,16, Andrew Carr17,18, Jeff Karp19, Ivan Wal20, David Brindley21
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View Affiliations Hide Affiliations1 The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK 2 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; 3 The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK 4 The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK 5 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK 6 The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK 7 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK 8 Saïd Business School, University of Oxford, Oxford, UK 9 Sir William Dunn School of Pathology, University of Oxford, Oxford, UK 10 The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK 11 Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK 12 Harvard Stem Cell Institute, Harvard University, Cambridge, MA, USA; 7Sartorius Stedim, Göttingen, Germany 13 Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough, LE11 3TU, UK 14 Harvard Stem Cell Institute, Harvard University, Cambridge, MA, USA 15 The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK 16 Sartorius Stedim, Göttingen, Germany 17 The Oxford - UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK 18 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK 19 Harvard Stem Cell Institute, Harvard University, Cambridge, MA, USA 20 Department of Biochemical Engineering, University College London, London, WC1H 0AH, UK 21 Saïd Business School, University of Oxford, Oxford, UK
- Source: Frontiers in Stem Cell and Regenerative Medicine Research: Volume 2 , pp 157-175
- Publication Date: April 2016
- Language: English


Challenges and Opportunities in the Development of Induced Pluripotent Stem Cell Therapeutics, Page 1 of 1
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Since their discovery in 2006, induced pluripotent stem cells (iPSCs) have generated much excitement as a potential source of therapeutic cells. Diverse applications, including for diabetes, neurological and ocular disorders, and heart failure are currently being investigated, and new therapies could enter into a growing regenerative medicine market. Despite this, there are significant challenges in the development of iPSC therapeutics and their ultimate translation to clinical use. Heterogeneity in iPSC products can be introduced throughout the complex process of iPSC generation and selection. Challenges with, and current approaches to, developing scalable, consistent methods for reprogramming of somatic cells, and selection, validation and characterization of iPSCs are, therefore, discussed in the context of good manufacturing guidelines and quality assurance. Further, we discuss issues and considerations with immuno-compatibility and the possible need for immune suppression. The final barrier to the development of iPSC therapeutics discussed is intellectual property.
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