Guide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments
Autor Joaquim Vives, Gloria Carmonaen Limba Engleză Paperback – 30 iul 2015
- 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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Specificații
ISBN-13: 9780128031155
ISBN-10: 0128031158
Pagini: 266
Dimensiuni: 152 x 229 x 15 mm
Greutate: 0.38 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0128031158
Pagini: 266
Dimensiuni: 152 x 229 x 15 mm
Greutate: 0.38 kg
Editura: ELSEVIER SCIENCE
Cuprins
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
Notă biografică
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.