國立高雄大學圖資館 |

Language: English

Back

Potency assays for advanced stem cell therapy medicinal products

Record Type:	Electronic resources : Monograph/item
Title/Author:	Potency assays for advanced stem cell therapy medicinal productsedited by Jorge S. Burns.
other author:	Burns, Jorge S.
Published:	Cham :Springer International Publishing :2023.
Description:	1 online resource (xix, 214 p.) :ill., digital ;24 cm.
Contained By:	Springer Nature eBook
Subject:	Stem cellsTherapeutic use.
Online resource:	https://doi.org/10.1007/978-3-031-30040-0
ISBN:	9783031300400$q(electronic bk.)

Potency assays for advanced stem cell therapy medicinal products
Potency assays for advanced stem cell therapy medicinal products[electronic resource] /edited by Jorge S. Burns. - Cham :Springer International Publishing :2023. - 1 online resource (xix, 214 p.) :ill., digital ;24 cm. - Advances in experimental medicine and biology,v. 14202214-8019 ;. - Advances in experimental medicine and biology ;946..

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.

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. 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.

ISBN: 9783031300400$q(electronic bk.)

Standard No.: 10.1007/978-3-031-30040-0doiSubjects--Topical Terms:

455512
Stem cells
--Therapeutic use.

LC Class. No.: QH588.S83

Dewey Class. No.: 616.02774

Potency assays for advanced stem cell therapy medicinal products
LDR:04763nmm a2200337 a 4500 001 637448
003 DE-He213
005 20230531183647.0
006 m d
007 cr nn 008maaau
008 230921s2023 sz s 0 eng d
020 $a 9783031300400$q(electronic bk.)
020 $a 9783031300394$q(paper)
024 7 $a 10.1007/978-3-031-30040-0 $2 doi
035 $a 978-3-031-30040-0
040 $a GP $c GP
041 0 $a eng
050 4 $a QH588.S83
072 7 $a PSC $2 bicssc
072 7 $a SCI017000 $2 bisacsh
072 7 $a PSC $2 thema
082 0 4 $a 616.02774 $2 23
090 $a QH588.S83 $b P861 2023
245 0 0 $a Potency assays for advanced stem cell therapy medicinal products $h [electronic resource] / $c edited by Jorge S. Burns.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2023.
300 $a 1 online resource (xix, 214 p.) : $b ill., digital ; $c 24 cm.
490 1 $a Advances in experimental medicine and biology, $x 2214-8019 ; $v v. 1420
505 0 $a 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.
520 $a 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. 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.
650 0 $a Stem cells $x Therapeutic use. $3 455512
650 1 4 $a Stem Cell Biology. $3 921011
650 2 4 $a Regenerative Medicine and Tissue Engineering. $3 913079
650 2 4 $a Medical Microbiology. $3 273931
700 1 $a Burns, Jorge S. $3 943894
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer Nature eBook
830 0 $a Advances in experimental medicine and biology ; $v 946. $3 557559
856 4 0 $u https://doi.org/10.1007/978-3-031-30040-0
950 $a Biomedical and Life Sciences (SpringerNature-11642)