rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Potency Assays for Advanced Stem Cell Therapy Medicinal Products
  name:
    name part: Burns, Jorge S.
    role:
      role term: editor.
    role:
      role term: edt
    role:
      role term: http://id.loc.gov/vocabulary/relators/edt
  name:
    name part: SpringerLink (Online service)
  type of resource: text
  genre: Electronic books.
  origin info:
    place:
      place term: sz
    date issued: 2023
    edition: 1st ed. 2023.
    issuance: monographic
  language:
    language term: eng
  physical description:
    reformatting quality: access
    form: remote
    extent: 1 online resource (XIX, 214 pages 1 illustrations)
  abstract: 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 as…
  table of contents: 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.
  note: edited by Jorge S. Burns.
  subject:
    topic: Stem cells
  subject:
    topic: Regenerative medicine
  subject:
    topic: Medical microbiology
  subject:
    topic: Stem Cell Biology
  subject:
    topic: Regenerative Medicine and Tissue Engineering
  subject:
    topic: Medical Microbiology
  classification: QH588.S83
  classification: 571.6
  classification: 616.02774
  related item:
    title info:
      title: Springer Nature eBook
  related item:
    title info:
      title: Advances in Experimental Medicine and Biology, 1420
  identifier: 9783031300400
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record creation date: 230531
    record change date: 20240805191634.7
    record identifier: in00004739830