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Guide to Cell Therapy GxP
Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments
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Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-Pharmaceutical Environments provides a practical guide to the implementation of quality assurance systems for successful performance of all cell-based clinical trials. The book includes all information that should be used in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond, bridging the gap in knowledge with the inclusion of examples of design of GLP-compliant preclinical studies, design of bioprocesses for autologous/allogeneic therapies, risk-based assessment of GMP-compliant processes for the production of cell-based therapies, and instructions on how to implement GLP/GMP standards in centers accredited with other quality assurance standards (JACIE; FACT/NETCORD, ISO9001, and others). * Provides easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge* Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data* Includes practical examples of successful implementation of quality standards
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