Potency Assays for Advanced Stem Cell Therapy Medicinal Products

Provides the reader with the knowledge necessary to understand the successful development of potency assays
Presents an international outlook and worldwide perspective of how the various challenges raised are being managed
Includes contributions from industry and companies which deal with regulatory agencies - breadth of applicability in many areas of science, industry and policy-making

Autorentext

Jorge S. Burns received his degree in Cellular Pathology at the University of Bristol and PhD at the University of Wales College of Medicine in 1992, authoring the first UK manuscript to describe the use of retroviral vectors in epithelial cells. At the Ludwig Institute for Cancer Research, University College London Branch, a postdoctoral fellowship in Breast Cancer research provided technology insights leading to an appointment at renowned proteome research facilities at the University of Southern Denmark in Odense. Subsequent industrial experience was obtained with management of a cell culture facility supporting mass spectrometry for immune therapy target discovery at MDS Proteomics A/S. Joining the academic research team led by Prof. Moustapha Kassem at Odense University Hospital brought focus on human bone marrow derived stromal cells and their osteogenic differentiation potential, plus participation in the Innovation Consortium 3-D scaffolds. Preclinical stem cell characterisation studies progressed to translational regenerative medicine at the University of Modena in Italy, upon joining the EU Framework 7 Reborne consortium, whereby bone therapy clinical trials required exploration of novel osteogenic potency assays. To pursue development of potency assay biosensors, Prof. Burns obtained an award for project number 154/25.11.2016, P37221/2015, "A novel GRaphene Biosensor Testing Osteogenic Potency; capturing best stem cell performance for regenerative medicine" (GRABTOP), from the Ministry of Research and Innovation in Romania, Operational Program Competitiveness Axis 1 Section E, co-financed from European Regional Development Fund "Investments for your future". The multidisciplinary laboratory inaugurated at the Faculty of Medical Engineering, University Politehnica of Bucharest, tested the applicability of the nanomaterial graphene and its diverse functionalised forms. Current research interests revolve around improved methods of in vivo mimicry at the Department of Environmental and Prevention Sciences at the University of Ferrara.

Inhalt

The Art of Cell Therapy.- Scope and Applicability of Autologous Cell Therapies.- Scale and Accessibility of Allogeneic Cell Therapies.- Acellular Stem Cell Products. Potency Assays: The Buggy Boo of Stem Cell Therapy.- Potency Assay Development: A Keystone for Clinical Use.- Quantifying Critical Quality Attributes.- Advanced Technologies for Potency Assay Measurement.- Potency Quality by Design: Tailoring for Specific Therapy.- Contract Research Organizations Expediting Therapeutic Availability.- Regulatory Authority Perspectives for Potency Release Criteria.- Illustrative Potency Assay Examples from Approved Therapies.- The Integrity of Potency Assays and Safe Intervention.- The Evolving Landscape of Potency Assays.