Guide to Cell Therapy Gx: P. Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments

__Guide to Cell Therapy GxP__ is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. __Guide to Cell Therapy GxP__ bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. __Guide to Cell Therapy GxP__ is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. • 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.

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

Content: Front Matter,Copyright,List of Contributors,Foreword,PrefaceEntitled to full text1 - Overview of the Development Program of a Cell-Based Medicine, Pages 1-13 2 - European Regulatory Framework for the Development of Cell-Based Medicines, Pages 15-47 3 - Nonclinical Studies for Cell-Based Medicines, Pages 49-106 4 - Good Manufacturing Practice Compliance in the Manufacture of Cell-Based Medicines, Pages 107-175 5 - Good Clinical Practice in Nonprofit Institutions, Pages 177-229 6 - Compatibility of GxP with Existing Cell Therapy Quality Standards, Pages 231-252 Index, Pages 253-262