Guide to Cell Therapy GxP: 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 knowledgeFeatures protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive dataIncludes practical examples of successful implementation of quality standards

Foreword
Preface
1. Overview of the development programme of a cell-based medicine
2. European regulatory framework for the development of cell-based medicines
3. Non-clinical studies for cell-based medicines
4. GMP compliance in the manufacture of cell-based medicines
5. GCP compliance in non-profit institutions
6. Compatibility of GxP with existing quality standards