LEADER 05811nam 22006255 450 001 9910728930103321 005 20250408035222.0 010 $a9783031300400$b(electronic bk.) 010 $z9783031300394 024 7 $a10.1007/978-3-031-30040-0 035 $a(MiAaPQ)EBC30558383 035 $a(Au-PeEL)EBL30558383 035 $a(OCoLC)1381095739 035 $a(DE-He213)978-3-031-30040-0 035 $a(BIP)089067253 035 $a(PPN)270612742 035 $a(CKB)26816395400041 035 $a(EXLCZ)9926816395400041 100 $a20230531d2023 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aPotency Assays for Advanced Stem Cell Therapy Medicinal Products /$fedited by Jorge S. Burns 205 $a1st ed. 2023. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2023. 215 $a1 online resource (226 pages) 225 1 $aAdvances in Experimental Medicine and Biology,$x2214-8019 ;$v1420 311 08$aPrint version: Burns, Jorge S. Potency Assays for Advanced Stem Cell Therapy Medicinal Products Cham : Springer International Publishing AG,c2023 9783031300394 327 $aThe 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. 330 $aThis 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 compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. ?Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology . 410 0$aAdvances in Experimental Medicine and Biology,$x2214-8019 ;$v1420 606 $aStem cells 606 $aRegenerative medicine 606 $aMedical microbiology 606 $aStem Cell Biology 606 $aRegenerative Medicine and Tissue Engineering 606 $aMedical Microbiology 615 0$aStem cells. 615 0$aRegenerative medicine. 615 0$aMedical microbiology. 615 14$aStem Cell Biology. 615 24$aRegenerative Medicine and Tissue Engineering. 615 24$aMedical Microbiology. 676 $a616.02774 676 $a616.02774 700 $aBurns$b Jorge S$01365625 702 $aBurns$b Jorge S.$4edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 912 $a9910728930103321 996 $aPotency Assays for Advanced Stem Cell Therapy Medicinal Products$93387802 997 $aUNINA