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

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 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 INDICE: 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

• ISBN: 978-0-12-803115-5
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 266
• Fecha Publicación: 12/10/2015
• Nº Volúmenes: 1
• Idioma: Inglés