Guide to Cell Therapy GxP

Erscheinungsjahr 2015
ISBN: 978-0-12-803115-5
Verlag: ACADEMIC PRESS

Buch, Englisch, 266 Seiten, Format (B × H): 151 mm x 228 mm, Gewicht: 411 g

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.

Autoren/Hrsg.

Vives, Joaquim

Carmona, Gloria

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Naturwissenschaften Biowissenschaften Zellbiologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Vorklinische Medizin: Grundlagenfächer Molekulare Medizin, Zellbiologie

Inhaltsverzeichnis

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

Über Autor(innen)

Carmona, Gloria
Dr. Carmona is a Pharmacist with experience in management and training. She also holds a Masters Degree in Manufacturing of Advanced Therapy Medicinal Products and has worked across Europe in the biotechnology sector training on quality systems and good manufacturing practices in advanced therapies medicinal products. She has been a Quality Assessment Manager and GMP facilities Manager from the inception of the Andalusian Initiative for Advanced Therapies in October 2008. Previously, she worked worked as Quality Assessment and Accreditation Manager in the Andalusian Program for Cell Therapy and Regenerative Medicine. She has also worked as a Quality Assurance Technician at Cellerix an international biotech headquartered in Belgium, Cambridge, and Madrid and Clinical Documentation Technician in Pfizer.

Vives, Joaquim
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.