Guide to Cell Therapy GxP

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

Dr. Vives has specialties in GLP/GMP implementation, the development of (stem) cell-based products for regenerative medicine, and design, execution and analysis of non-clinical studies. He was a post-doctoral Fellow at University of Edinburgh and moved to Stem Cell Sciences Ltd in the UK where he became Head of Research. Six years ago, he became Head of Preclinical Studies at XCELIA, a biopharmaceutical company formed from The Catalan Blood and Tissue Service (Banc de Sang i Teixits) devoted to the development of advanced therapy medicine. As the Quality manager at XCelia, Dr. Vives secured the facility as the first GLP-compliant laboratory in Spain dedicated to the development of advanced cell therapies. He is now Director of R&D, responsible for technology transfer of innovative experimental bioprocesses into GMP-compliant production environments. He also manages GLP test facilities and relationships with Health Regulatory Agencies among other compliance responsibilities.