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Insights In Regulatory Science 2021

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Insights In Regulatory Science 2021

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Author : Bruno Sepodes
language : en
Publisher: Frontiers Media SA
Release Date : 2022-11-04

Insights In Regulatory Science 2021 written by Bruno Sepodes and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-04 with Medical categories.

Potency Assays For Advanced Stem Cell Therapy Medicinal Products

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Author : Jorge S. Burns
language : en
Publisher: Springer Nature
Release Date : 2023-05-31

Potency Assays For Advanced Stem Cell Therapy Medicinal Products written by Jorge S. Burns and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-31 with Science categories.

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

Navigating Law And Policy In Stm Enterprises Ethical Governance Regulation And Innovation Strategy

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Author : Zangana, Hewa Majeed
language : en
Publisher: IGI Global
Release Date : 2025-06-13

Navigating Law And Policy In Stm Enterprises Ethical Governance Regulation And Innovation Strategy written by Zangana, Hewa Majeed and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-13 with Business & Economics categories.

To understand the world of Science, Technology, and Medicine (STM) enterprises, it is essential to navigate the complex landscape of law and policy. STM sectors often outpace existing legal frameworks and policies raising unique challenges related to intellectual property, data privacy, and ethical considerations. As STM enterprises develop groundbreaking products and services, understanding and adapting to evolving legal and policy environments becomes essential for sustainable growth, risk management, and public trust. This intersection of law, policy, and technological advancement demands strategic foresight and informed decision-making to ensure responsible and lawful innovation. Navigating Law and Policy in STM Enterprises: Ethical Governance, Regulation, and Innovation Strategy explores the legal and policy landscape that surrounds STM firms and the legal challenges they face. It shows a strategic roadmap of reducing litigation risk while preserving competitive agility. Covering topics such as law, policies, and STM, this book is an excellent resource for STM executives, in-house counsel, compliance officers, policy analysts, researchers, academicians, and more.

Women In Science Regulatory Science 2021

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Author : Mette Due Theilade Thomsen
language : en
Publisher: Frontiers Media SA
Release Date : 2023-04-12

Women In Science Regulatory Science 2021 written by Mette Due Theilade Thomsen and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-12 with Medical categories.

Insights In Virology 2021

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Author : Chunfu Zheng
language : en
Publisher: Frontiers Media SA
Release Date : 2023-04-28

Insights In Virology 2021 written by Chunfu Zheng and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-28 with Science categories.

Insights In Plant Metabolism And Chemodiversity 2021

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Author : Laigeng Li
language : en
Publisher: Frontiers Media SA
Release Date : 2023-02-03

Insights In Plant Metabolism And Chemodiversity 2021 written by Laigeng Li and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-02-03 with Science categories.

Insights In Immunological Tolerance And Regulation 2022

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Author : Lucienne Chatenoud
language : en
Publisher: Frontiers Media SA
Release Date : 2023-10-25

Insights In Immunological Tolerance And Regulation 2022 written by Lucienne Chatenoud and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-10-25 with Medical categories.