Guide to Cell Therapy GxP
Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments

This book provides the quality standards used in the development of stem cell-based medicines in non-pharmaceutical environments, and includes all information that should be used in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation.

Joaquim Vives (Author), Gloria Carmona (Author)

9780128031155, Elsevier Science

Paperback, published 30 July 2015

266 pages
22.9 x 15.1 x 1.8 cm, 0.45 kg

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.

ForewordPreface1. Overview of the development programme of a cell-based medicine 2. European regulatory framework for the development of cell-based medicines3. Non-clinical studies for cell-based medicines4. GMP compliance in the manufacture of cell-based medicines5. GCP compliance in non-profit institutions6. Compatibility of GxP with existing quality standards

Subject Areas: Cellular biology [cytology PSF], Biomedical engineering [MQW]