Burns J. Potency Assays for Advanced Stem Cell Therapy Medicinal Products 2023

Textbook in PDF format

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 from clinical, 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 compromise and the authors aim to constructively address the many key aspects involved.
The Art of Stem Cell-Based Therapy
Potency Assay Development: A Keystone for Clinical Use
Potency Assays: The ‘Bugaboo’ of Stem Cell Therapy
Identifying Biomarkers for Osteogenic Potency Assay Development
Potency Assay Considerations for Cartilage Repair, Osteoarthritis and Use of Extracellular Vesicles
Advanced Technologies for Potency Assay Measurement
Innovative Quantification of Critical Quality Attributes
Release Assays and Potency Assays for CAR T-Cell Interventions
Illustrative Potency Assay Examples from Approved Therapies
From the Integrity of Potency Assays to Safe Clinical Intervention: Legal Perspectives
The Evolving Landscape of Potency Assays