Advances in Pharmaceutical Cell Therapy

Advances in Pharmaceutical Cell Therapy
By:"Christine Günther","Andrea Hauser","Ralf Huss"
Published on 2015-09-23 by World Scientific

This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it. The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies. This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity. Contents:About this Book: Why Cell Therapy?Regulatory Landscape and Risk-Based ApproachNon-Clinical Development of Cell-Based ProductsQuality ManagementProcess Development and ManufacturingQuality ControlCell BankingProduct ReleaseClinical Development of Cell-Based ProductsPharmacovigilance and Look-Back ProceduresPersonalized Cell Therapy–Biomarker & Companion DiagnosticsMesenchymal Stem CellsNext Generation Cell TherapiesCell-Based Gene TherapyExosomes and their Therapeutic ApplicationsCommercial and Business Aspects of Cell Therapy — Start-Up to Market Readership: Students, researchers in biomedical, stem cell and molecular biology; Pharmaceutical business professionals. Keywords:Commercial Landscape on Cell Therapeutics;Regulatory Landscape;Preclinical and Clinical Development;Clinical Trial Application and Design;(Stem) Cell Banking;Quality Control and Management;Personalized Cell Therapy;Economics of Cell-Based TherapeuticsReview: \

This Book was ranked 5 by Google Books for keyword Terapy.

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