Guide to Cell Therapy GxP

Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments

Autor: Joaquim Vives, Gloria Carmona

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Editura: Elsevier Books

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

Informații despre carte

Autor

Joaquim Vives, Gloria Carmona

Limbă

engleză

Legare

Carte - Carte broșată

Publicat

2015

Pagini

266

EAN

9780128031155

ISBN

0128031158

Enbook ID

09482526

Editura

Elsevier Books

Greutate

410

Dimensiuni

230 x 154 x 21

Descriere completă

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

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Guide to Cell Therapy GxP

Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments

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