书目名称 | Potency Assays for Advanced Stem Cell Therapy Medicinal Products |
编辑 | Jorge S. Burns |
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概述 | Provides the reader with the knowledge necessary to understand the successful development of potency assays.Presents an international outlook and worldwide perspective.Includes contributions from indu |
丛书名称 | Advances in Experimental Medicine and Biology |
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描述 | .This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors fromclinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as |
出版日期 | Book 2023 |
关键词 | potency assay; stem cell therapy; autologous cell; acellular; extracellular vesicles |
版次 | 1 |
doi | https://doi.org/10.1007/978-3-031-30040-0 |
isbn_softcover | 978-3-031-30042-4 |
isbn_ebook | 978-3-031-30040-0Series ISSN 0065-2598 Series E-ISSN 2214-8019 |
issn_series | 0065-2598 |
copyright | Springer Nature Switzerland AG 2023 |