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Potency Assays for Advanced Stem Cell Therapy Medicinal Products

Potency Assays for Advanced Stem Cell Therapy Medicinal Products
Potency Assays for Advanced Stem Cell Therapy Medicinal Products

Potency Assays for Advanced Stem Cell Therapy Medicinal Products

Hardback / bound | English
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Description

The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potencyassay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval.

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, P_37_221/2015, “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 mimicryat the Department of Environmental and Prevention Sciences at the University of Ferrara.

Specifications

  • Publisher
    Springer International Publishing AG
  • Pub date
    Jun 2023
  • Theme
    Regenerative medicine
  • Dimensions
    254 x 178 mm
  • EAN
    9783031300394
  • Hardback / bound
    Hardback / bound
  • Language
    English